Drug
Who makes nicardipine hydrochloride?
28 companies list nicardipine hydrochloride as a human prescription drug, including under the names Cardene IV. Forms: capsule; injection; injection, solution. Routes: intravenous, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing nicardipine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Baxter Healthcare CorporationUnited States | injection, solution | NDANDA019734 | 7 | 16 |
| Hikma Pharmaceuticals USA Inc.United States | injection | NDANDA022276 | 4 | 4 |
| Glenmark Pharmaceuticals Inc., USAIndia | capsule | ANDAANDA216357 | 2 | 9 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | injection | ANDAANDA215592 | 2 | 7 |
| Epic Laboratories, LLCUnited States | capsule | ANDAANDA074928 | 2 | 3 |
| ANI Pharmaceuticals, Inc.United States | capsule | ANDAANDA074670 | 2 | 1 |
| Bionpharma Inc.India | capsule | ANDAANDA217555 | 2 | 1 |
| CAPLIN STERILES LIMITEDIndia | injection | ANDAANDA220243 | 2 | 1 |
| Somerset Therapeutics Private LimitedIndia | injection | ANDAANDA220243 | 2 | 1 |
| Amerisyn, LLC | capsule | ANDAANDA215377 | 2 | 0 |
| Amici Pharmaceuticals, LLC. | capsule | ANDAANDA215377 | 2 | 0 |
| Burel Pharmaceuticals, LLC | capsule | ANDAANDA215377 | 2 | 0 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals | capsule | ANDAANDA074928 | 2 | 0 |
| WG Critical Care, LLC. | injection, solution | ANDAANDA203978 | 2 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection | ANDAANDA217548 | 1 | 6 |
| American Regent, Inc.United States | injection, solution | ANDAANDA090534 | 1 | 5 |
| Micro Labs LimitedIndia | injection | ANDAANDA216420 | 1 | 5 |
| Qilu Pharmaceutical Co., Ltd.China | injection, solution | ANDAANDA219608 | 1 | 5 |
| Chengdu Shuode Pharmaceutical Co.,LtdChina | injection | ANDAANDA217548 | 1 | 1 |
| Civica, Inc. dba CivicaRxUnited States | injection, solution | ANDAANDA090534 | 1 | 1 |
| HF Acquisition Co LLCUnited States | injection | NDANDA022276 | 1 | 1 |
| Archis Pharma LLC | injection, solution | ANDAANDA090664 | 1 | 0 |
| Armas Pharmaceuticals, Inc. | injection | ANDAANDA216420 | 1 | 0 |
| Eugia US LLC | injection, solution | ANDAANDA211121 | 1 | 0 |
| Lifestar Pharma LLC. | injection | ANDAANDA090671 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection, solution | ANDAANDA216819 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA219608 | 1 | 0 |
| West-Ward Pharmaceuticals Corp | injection | NDANDA022276 | 1 | 0 |
Bulk ingredient listings
- Lusochimica SPAItaly · 2 NDC
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- Sichuan Qingmu Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
6 unexpired patents list nicardipine hydrochloride as the active ingredient, expiring between Apr 2027 and Dec 2027. Application holder: CHIESI USA INC.
Enquiry
Common questions
- Who makes nicardipine hydrochloride?
- 28 companies list nicardipine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Baxter Healthcare Corporation, Hikma Pharmaceuticals USA Inc., Glenmark Pharmaceuticals Inc., USA, CIPLA PHARMACEUTICALS LIMITED, Epic Laboratories, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Cardene IV?
- 24 companies list nicardipine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies nicardipine hydrochloride active ingredient?
- 6 companies list nicardipine hydrochloride as a bulk ingredient, including Lusochimica SPA, APOTHECON PHARMACEUTICALS PRIVATE LIMITED, MSN Laboratories Private Limited,, Metrochem API Private Limited.