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Data / Drug companies / Nicardipine hydrochloride

Nicardipine hydrochloride: 27 companies and 52 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Nicardipine hydrochloride is listed in the FDA National Drug Code Directory by 27 companies, with 52 products in commercial distribution. 39 of the products (75.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; injection, solution; capsule, and the newest product started marketing on October 1, 2026.

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Companies listing it
27
Products
52
Generic (ANDA) products
39 (75.0%)
Application numbers
19
Routes
Intravenous, Oral
Brand names
Cardene IV, Cardene IV
openFDA record search
api.fda.gov

Companies that list nicardipine hydrochloride

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Baxter Healthcare Corporation7injection, solutionNew drug applications (NDA)January 30, 1992
Hikma Pharmaceuticals USA Inc.5injectionNew drug applications (NDA)April 7, 2016
Fresenius Kabi USA, LLC3injectionGeneric drugs (ANDA)October 1, 2026
Amerisyn LLC2capsuleGeneric drugs (ANDA)July 26, 2026
Amici Pharma, Inc.2capsuleGeneric drugs (ANDA)January 15, 2026
Ani Pharmaceuticals, Inc.2capsuleGeneric drugs (ANDA)June 25, 2021
Bionpharma Inc.2capsuleGeneric drugs (ANDA)November 4, 2024
Burel Pharmaceuticals, LLC2capsuleGeneric drugs (ANDA)January 8, 2023
Caplin Steriles Limited2injectionGeneric drugs (ANDA)June 25, 2026
Cipla USA Inc.2injectionGeneric drugs (ANDA)October 2, 2024
Epic Pharma, LLC2capsuleGeneric drugs (ANDA)May 5, 2010
Eugia US LLC2injection, solutionGeneric drugs (ANDA)April 8, 2021
Glenmark Pharmaceuticals Inc., USA2capsuleGeneric drugs (ANDA)December 16, 2022
Puracap Laboratories LLC DBA Blu Pharmaceuticals2capsuleGeneric drugs (ANDA)December 15, 2016
Somerset Therapeutics, LLC2injectionGeneric drugs (ANDA)April 20, 2026
WG Critical Care, LLC2injection, solutionGeneric drugs (ANDA)July 10, 2025
American Regent, Inc.1injection, solutionGeneric drugs (ANDA)May 8, 2020
Archis Pharma LLC1injection, solutionGeneric drugs (ANDA)December 7, 2024
Armas Pharmaceuticals Inc.1injectionGeneric drugs (ANDA)April 3, 2024
Chengdu Shuode Pharmaceutical Co., Ltd1injectionGeneric drugs (ANDA)September 11, 2024
Civica, Inc.1injection, solutionGeneric drugs (ANDA)October 29, 2020
HF Acquisition Co LLC, DBA HealthFirst1injectionNew drug applications (NDA)February 1, 2020
Lifestar Pharma LLC1injectionGeneric drugs (ANDA)February 24, 2026
Meitheal Pharmaceuticals Inc.1injection, solutionGeneric drugs (ANDA)August 20, 2025
Micro Labs Limited1injectionGeneric drugs (ANDA)November 1, 2023
Qilu Pharmaceutical Co., Ltd.1injection, solutionGeneric drugs (ANDA)October 28, 2025
Sagent Pharmaceuticals1injection, solutionGeneric drugs (ANDA)January 1, 2026

Dosage forms

Dosage formProductsShare
Injection1936.5%
Injection, solution1732.7%
Capsule1630.8%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)3975%
New drug applications (NDA)1325%

Pharmacologic classes

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.