Data / Drug companies / Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc.: 375 products in the FDA NDC directory, labeler code 0378
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Mylan Pharmaceuticals Inc. (labeler code 0378) lists 375 products in the FDA National Drug Code Directory, covering 140 finished drugs by generic name. By type: 366 prescription drugs, 6 drugs for further processing. Its main marketing category is generic drugs (ANDA). The newest product started marketing on June 8, 2026.
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- Labeler code
- 0378
- Products in commercial distribution
- 375
- Packages
- 501
- Finished drugs by generic name
- 140
- Prescription products
- 366
- Over the counter products
- 3
- Controlled substance products
- Schedule II 19, Schedule III 4, Schedule IV 11
- Flagged as original packager
- 329 of 329 products that carry the flag
- Started marketing in the last 12 months
- 1
- Products with a marketing end date set
- 27
- Earliest marketing start
- August 3, 1979
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 351 | 93.6% |
| Authorized generics (NDA) | 12 | 3.2% |
| Drugs for further processing | 6 | 1.6% |
| New drug applications (NDA) | 6 | 1.6% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 366 | 97.6% |
| Drugs for further processing | 6 | 1.6% |
| Over the counter drugs | 3 | 0.8% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 121 | 32.3% |
| Tablet | 74 | 19.7% |
| Capsule | 45 | 12% |
| Patch | 40 | 10.7% |
| Kit | 13 | 3.5% |
| Cream | 11 | 2.9% |
| Capsule, extended release | 10 | 2.7% |
| Tablet, film coated, extended release | 10 | 2.7% |
| Solution | 9 | 2.4% |
| Capsule, delayed release pellets | 6 | 1.6% |
| Tablet, orally disintegrating | 4 | 1.1% |
| Gel | 4 | 1.1% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Macitentan | 0378-0606 | Tablet, film coated | Generic drugs (ANDA) | June 8, 2026 |
| Difluprednate | 0378-7518 | Emulsion | Generic drugs (ANDA) | September 26, 2025 |
| Ticagrelor | 0378-2215 | Tablet, film coated | Generic drugs (ANDA) | September 25, 2025 |
| Ticagrelor | 0378-2214 | Tablet, film coated | Generic drugs (ANDA) | September 25, 2025 |
| Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate | 0378-5440 | Tablet, film coated | Generic drugs (ANDA) | May 27, 2025 |
| Amnesteem | 0378-6613 | Capsule | Generic drugs (ANDA) | April 10, 2025 |
| Ferric Citrate | 0378-2895 | Tablet, film coated | Authorized generics (NDA) | March 20, 2025 |
| Glucagon | 0378-8067 | Kit | Generic drugs (ANDA) | February 26, 2025 |
| Dabigatran Etexilate | 0378-0266 | Capsule | Generic drugs (ANDA) | February 25, 2025 |
| Dabigatran Etexilate | 0378-0265 | Capsule | Generic drugs (ANDA) | February 25, 2025 |
| Dexlansoprazole | 0378-2086 | Capsule, delayed release pellets | Generic drugs (ANDA) | January 22, 2024 |
| Dexlansoprazole | 0378-2085 | Capsule, delayed release pellets | Generic drugs (ANDA) | January 22, 2024 |
| Pitavastatin Calcium | 0378-5057 | Tablet, film coated | Generic drugs (ANDA) | November 2, 2023 |
| Pitavastatin Calcium | 0378-5056 | Tablet, film coated | Generic drugs (ANDA) | November 2, 2023 |
| Pitavastatin Calcium | 0378-5055 | Tablet, film coated | Generic drugs (ANDA) | November 2, 2023 |
| Lisdexamfetamine Dimesylate | 0378-6860 | Capsule | Generic drugs (ANDA) | August 25, 2023 |
| Lisdexamfetamine Dimesylate | 0378-6859 | Capsule | Generic drugs (ANDA) | August 25, 2023 |
| Lisdexamfetamine Dimesylate | 0378-6858 | Capsule | Generic drugs (ANDA) | August 25, 2023 |
| Lisdexamfetamine Dimesylate | 0378-6857 | Capsule | Generic drugs (ANDA) | August 25, 2023 |
| Lisdexamfetamine Dimesylate | 0378-6856 | Capsule | Generic drugs (ANDA) | August 25, 2023 |
| Lisdexamfetamine Dimesylate | 0378-6855 | Capsule | Generic drugs (ANDA) | August 25, 2023 |
| Lisdexamfetamine Dimesylate | 0378-6854 | Capsule | Generic drugs (ANDA) | August 25, 2023 |
| Clozapine | 0378-3817 | Tablet, orally disintegrating | Generic drugs (ANDA) | August 16, 2023 |
| Clozapine | 0378-3816 | Tablet, orally disintegrating | Generic drugs (ANDA) | August 16, 2023 |
| Saxagliptin and Metformin | 0378-8177 | Tablet, film coated, extended release | Generic drugs (ANDA) | August 8, 2023 |
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.