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Data / Drug companies / New drug applications (NDA)

Companies that list new drug applications (nda) products: 1,036 companies and 7,381 products in the FDA NDC directory

The FDA National Drug Code Directory lists 7,381 products that are drugs marketed under a new drug application (NDA) from 1,036 companies. The ten largest listers hold 16.8% of them, and the newest started marketing on November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the National Drug Code Directory that FDA publishes, and this page is that reading. Ask for the companies that make a drug, a class or a dosage form, with their headquarters, website and size added from the web, and new listings and discontinued products arrive in your sheet, CRM, Slack or agent as FDA posts them.

Companies
1,036
Products
7,381
Drugs by generic name
1,708
Main marketing category
New drug applications (NDA)

Companies with the most new drug applications (nda)

Ranked by number of products in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Baxter Healthcare Corporation214injection, solution; injectionNew drug applications (NDA)October 19, 2026
A-S Medication Solutions150tablet, film coated; injection, solutionNew drug applications (NDA)April 27, 2026
Novartis Pharmaceuticals Corporation143tablet, film coated; tabletNew drug applications (NDA)September 30, 2025
Hospira, Inc.138injection, solution; injection, solution, concentrateNew drug applications (NDA)March 16, 2026
Fresenius Kabi USA, LLC127injection, solution; injection, powder, lyophilized, for solutionNew drug applications (NDA)March 13, 2025
Pfizer Laboratories Div Pfizer Inc112tablet, film coated; capsuleNew drug applications (NDA)January 5, 2026
HF Acquisition Co LLC, DBA HealthFirst110injection, solution; injectionNew drug applications (NDA)March 16, 2026
Eli Lilly and Company89injection, solution; tablet, film coatedNew drug applications (NDA)April 1, 2026
B. Braun Medical Inc.79injection, solution; injectionNew drug applications (NDA)October 1, 2026
Viatris Specialty LLC77tablet, film coated; capsuleNew drug applications (NDA)September 28, 2026
GlaxoSmithKline LLC71tablet, film coated; powderNew drug applications (NDA)October 20, 2026
Pharmacia & Upjohn Company LLC71injection, solution; injection, powder, for solutionNew drug applications (NDA)December 30, 2024
Bausch Health US LLC70tablet, extended release; tabletNew drug applications (NDA)October 20, 2023
AbbVie Inc.65tablet; kitNew drug applications (NDA)September 25, 2026
Bayer HealthCare Pharmaceuticals Inc.63injection; tablet, film coatedNew drug applications (NDA)June 12, 2026
Janssen Pharmaceuticals, Inc.63tablet, film coated; tablet, extended releaseNew drug applications (NDA)December 1, 2021
AstraZeneca Pharmaceuticals LP56tablet, film coated; tablet, film coated, extended releaseNew drug applications (NDA)September 4, 2026
Merck Sharp & Dohme LLC55tablet, film coated; injection, solutionNew drug applications (NDA)July 15, 2026
Icu Medical Inc.53injection, solution; irrigantNew drug applications (NDA)October 1, 2021
Organon LLC50tablet, film coated; tabletNew drug applications (NDA)December 1, 2025
Boehringer Ingelheim Pharmaceuticals, Inc.49tablet, film coated; tablet, extended releaseNew drug applications (NDA)October 7, 2025
Gilead Sciences, Inc.49tablet, film coated; tabletNew drug applications (NDA)October 31, 2026
Henry Schein, Inc.49injection, solution; injectionNew drug applications (NDA)June 24, 2026
Hikma Pharmaceuticals USA Inc.48injection; injection, powder, for solutionNew drug applications (NDA)October 22, 2026
Roberts Oxygen Company, Inc.44gasNew drug applications (NDA)November 17, 2025
Fenwal, Inc.42solution; kitNew drug applications (NDA)October 3, 2025
Hikma Pharmaceuticals USA Inc.42injection; injection, solutionNew drug applications (NDA)August 29, 2025
H2-Pharma, LLC41tablet; tablet, film coatedNew drug applications (NDA)August 18, 2025
Haleon US Holdings LLC41tablet, coated; suspensionNew drug applications (NDA)January 15, 2025
Medical Purchasing Solutions, LLC41injection, solution; injectionNew drug applications (NDA)August 19, 2024
Cardinal Health 107, LLC40tablet, film coated; injection, solutionNew drug applications (NDA)May 12, 2026
Par Health USA, LLC40injection; injection, powder, lyophilized, for solutionNew drug applications (NDA)October 27, 2025
Azurity Pharmaceuticals, Inc.38solution; tabletNew drug applications (NDA)April 17, 2026
Lil' Drug Store Products, Inc.38tablet, film coated; tabletNew drug applications (NDA)July 10, 2024
Vanda Pharmaceuticals Inc.38tablet; kitNew drug applications (NDA)July 1, 2026
Allergan, Inc.37tablet; tablet, film coatedNew drug applications (NDA)March 24, 2023
Ibsa Pharma Inc.36capsule; solutionNew drug applications (NDA)February 15, 2026
E.r. Squibb & Sons, L.L.C.35tablet; tablet, film coatedNew drug applications (NDA)August 13, 2026
Haleon US Holdings LLC34gum, chewing; lozengeNew drug applications (NDA)April 1, 2026
Sandoz Inc34patch, extended release; capsule, extended releaseNew drug applications (NDA)July 7, 2017
United Therapeutics Corporation34kit; inhalantNew drug applications (NDA)November 7, 2025
Otsuka America Pharmaceutical, Inc.33tablet; kitNew drug applications (NDA)October 24, 2026
WG Critical Care, LLC32injection, solution; injectionNew drug applications (NDA)March 21, 2025
Avyxa Pharma, LLC31injection; injection, solutionNew drug applications (NDA)October 29, 2026
Bausch & Lomb Incorporated31solution/ drops; solutionNew drug applications (NDA)March 19, 2026
Cosette Pharmaceuticals, Inc.31tablet, film coated; tablet, coatedNew drug applications (NDA)April 1, 2026
Ani Pharmaceuticals, Inc.30tablet; capsule, extended releaseNew drug applications (NDA)February 28, 2025
Takeda Pharmaceuticals America, Inc.30tablet, film coated; tabletNew drug applications (NDA)February 9, 2024
Bracco Diagnostics Inc29injection, solution; injectionNew drug applications (NDA)January 1, 2026
Novo Nordisk29injection, solution; tabletNew drug applications (NDA)April 27, 2026
Remedyrepack Inc.29injection, solution; tablet, film coatedNew drug applications (NDA)August 23, 2026
Takeda Pharmaceuticals America, Inc.29capsule, extended release; tablet, extended releaseNew drug applications (NDA)December 14, 2018
ProPharma Distribution28injection, solution; injectionNew drug applications (NDA)January 30, 2023
Validus Pharmaceuticals LLC28tablet; tablet, sugar coatedNew drug applications (NDA)October 1, 2026
Hikma Pharmaceuticals USA Inc.27tablet; capsule, gelatin coatedNew drug applications (NDA)August 16, 2026
Matheson Tri-Gas, Inc.27gasNew drug applications (NDA)January 1, 1987
Ucb, Inc.27tablet, film coated; patch, extended releaseNew drug applications (NDA)March 1, 2026
Fresenius Kabi USA, LLC26injection, solution; emulsionNew drug applications (NDA)July 29, 2026
ViiV Healthcare Company26tablet, film coated; kitNew drug applications (NDA)January 21, 2025
Astellas Pharma US, Inc.25tablet; capsuleNew drug applications (NDA)May 16, 2023
Kenvue Brands LLC25suspension; tablet, chewableNew drug applications (NDA)June 2, 2025
Allergan, Inc.24solution/ drops; emulsionNew drug applications (NDA)December 1, 2021
Almatica Pharma LLC24capsule; tablet, film coatedNew drug applications (NDA)July 1, 2026
Celgene Corporation24capsule; tablet, film coatedNew drug applications (NDA)September 1, 2020
Curium US LLC24injection, solution; injection, powder, lyophilized, for solutionNew drug applications (NDA)September 14, 2026
Eisai Inc.24tablet, film coated; tabletNew drug applications (NDA)April 7, 2020
Sportpharm LLC24injection, solution; sprayNew drug applications (NDA)January 9, 2026
Xttrium Laboratories, Inc.24solution; liquidNew drug applications (NDA)December 14, 2023
Bayer HealthCare LLC.23tablet; tablet, chewableNew drug applications (NDA)May 22, 2024
Walgreen Company23capsule, liquid filled; patch, extended releaseNew drug applications (NDA)June 19, 2026
Waylis Therapeutics LLC23tablet, film coated; capsuleNew drug applications (NDA)September 11, 2025
American Regent, Inc.22injection, solution; injectionNew drug applications (NDA)August 19, 2025
Janssen Products, LP22tablet, film coated; tabletNew drug applications (NDA)February 27, 2026
Actelion Pharmaceuticals US, Inc.21tablet, coated; tablet, film coatedNew drug applications (NDA)May 23, 2026
Baxter Healthcare Company21injection; injection, powder, for solutionNew drug applications (NDA)December 15, 2022
Bayer HealthCare LLC.21tablet; capsule, liquid filledNew drug applications (NDA)April 4, 2023
U.S. Pharmaceuticals21tablet, film coated; capsule, liquid filledNew drug applications (NDA)July 9, 2024
Amgen, Inc20tablet, coated; kitNew drug applications (NDA)August 29, 2025
Chattem, Inc.20tablet, film coated; tabletNew drug applications (NDA)May 1, 2026
Pfizer Laboratories Div Pfizer Inc20tablet; injection, suspensionNew drug applications (NDA)May 25, 2001
Proficient Rx LP20tablet; tablet, film coatedNew drug applications (NDA)May 7, 2019
Roerig20injection, powder, lyophilized, for solution; capsuleNew drug applications (NDA)February 20, 2024
SpecGx LLC20capsule; concentrateNew drug applications (NDA)June 1, 2015
Vertex Pharmaceuticals Incorporated20granule; kitNew drug applications (NDA)January 30, 2025
Alcon Laboratories, Inc.19solution; solution/ dropsNew drug applications (NDA)October 16, 2026
Knoa Pharma LLC19tablet, film coated, extended release; tablet, extended releaseNew drug applications (NDA)August 7, 2025
Legacy Pharma USA Inc.19tablet; capsuleNew drug applications (NDA)September 10, 2026
Takeda Pharmaceuticals America, Inc.19tablet, film coated; kitNew drug applications (NDA)August 28, 2026
Alvogen Inc.18tablet; injection, solutionNew drug applications (NDA)June 6, 2025
Amneal Pharmaceuticals LLC18capsule, extended release; granuleNew drug applications (NDA)May 16, 2025
Aphena Pharma Solutions - Tennessee, LLC18tablet, film coated; capsuleNew drug applications (NDA)June 21, 2019
Civica, Inc.18injection; injection, powder, lyophilized, for solutionNew drug applications (NDA)August 18, 2026
Covis Pharma US, Inc18injection, solution; tablet, film coated, extended releaseNew drug applications (NDA)October 29, 2019
Genentech, Inc.18tablet, film coated; capsuleNew drug applications (NDA)May 30, 2025
Mylan Institutional LLC18injection, solution; injection, powder, lyophilized, for solutionNew drug applications (NDA)April 15, 2020
Noven Therapeutics, LLC18film, extended release; patch, extended releaseNew drug applications (NDA)May 15, 2023
Advanz Pharma (US) Corp.17tablet; capsuleNew drug applications (NDA)May 19, 2025
Amneal Pharmaceuticals LLC17injection; kitNew drug applications (NDA)April 18, 2025
GVS TM Inc17solutionNew drug applications (NDA)June 24, 2026
Preferred Pharmaceuticals Inc.17tablet; creamNew drug applications (NDA)August 20, 2026

Drugs most often listed

DrugProducts hereCompanies listing it
Oxygen207432
Alcohol3293
Menthol1263
Lidocaine3216
Acetaminophen11214
Ibuprofen43190
Hydrocortisone9171
Famotidine6138
Lidocaine hydrochloride26134
Nitrogen130129
Loratadine21125
Guaifenesin14123
Cetirizine hydrochloride20119
Minoxidil4113
Diclofenac sodium3109
Omeprazole75106
Miconazole nitrate13101
Naproxen sodium53100
Clotrimazole698
Gabapentin1391
Levetiracetam2287
Potassium chloride2284
Loperamide hydrochloride2982
Benzoyl peroxide182
Metformin hydrochloride379
Phenylephrine hydrochloride1577
Triamcinolone acetonide1477
Esomeprazole magnesium1177
Sodium chloride6371
Fluticasone propionate871
Acyclovir370
Ketorolac tromethamine469
Metronidazole868
Bupropion hydrochloride667
Polyethylene glycol 3350467
Methocarbamol367
Capsaicin366
Baclofen1365
Fexofenadine hydrochloride1365
Glycopyrrolate964
Oxymetazoline hydrochloride364
Furosemide4263
Celecoxib663
Doxycycline263
Cyclobenzaprine hydrochloride361
Doxycycline hyclate261
Atorvastatin calcium459
Lansoprazole1158
Povidone-iodine158
Nicotine polacrilex2757
Lacosamide957
Topiramate1656
Fenofibrate756
Diltiazem hydrochloride2255
Sertraline hydrochloride655
Pregabalin1354
Pantoprazole sodium1154
Allopurinol754
Tadalafil554
Meloxicam454
Estradiol3253
Carbamazepine1152
Levocetirizine dihydrochloride752
Lamotrigine2651
Diazepam1051
Propranolol hydrochloride1051
Sodium bicarbonate251
Hydrochlorothiazide151
Aripiprazole1549
Olanzapine1449
Amlodipine besylate649
Dextromethorphan hydrobromide, guaifenesin149
Cetirizine hcl2348
Divalproex sodium648
Sulfamethoxazole and trimethoprim648
Venlafaxine hydrochloride348
Lidocaine hcl248
Fluconazole148
Albuterol sulfate1446
Metoprolol succinate1346
Oxcarbazepine746
Metoprolol tartrate446
Verapamil hydrochloride346
Dexamethasone445
Doxepin hydrochloride445
Clonidine hydrochloride345
Spironolactone345
Levothyroxine sodium16144
Fluoxetine hydrochloride344
Tramadol hydrochloride344
Risperidone2743
Labetalol hydrochloride543
Losartan potassium443
Mirtazapine542
Bumetanide442
Diclofenac potassium342
Chlorthalidone242
Docosanol142
Carbidopa and levodopa1141
Mesalamine641

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.