Drug
Who makes isosorbide dinitrate?
18 companies list isosorbide dinitrate as a human prescription drug. Forms: tablet. Routes: 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 isosorbide dinitrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA213057 | 5 | 12 |
| Par Health USA, LLCIndia | tablet | ANDAANDA086923, ANDA086925, ANDA087537 | 5 | 5 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA213057 | 5 | 1 |
| Advagen Pharma Limited | tablet | ANDAANDA215723 | 5 | 0 |
| BluePoint Laboratories Inc. | tablet | ANDAANDA086066, ANDA086067, ANDA088088 | 4 | 0 |
| Northstar Rx, LLC, | tablet | ANDAANDA213057 | 4 | 0 |
| Sandoz Industrial Products S.AAustria | tablet | ANDAANDA086221, ANDA086223, ANDA089367 | 3 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA088088 | 3 | 4 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA088088 | 3 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA215723 | 3 | 1 |
| AvPAK | tablet | ANDAANDA086923, ANDA086925, ANDA087537 | 3 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA088088 | 2 | 34 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA086925, ANDA087537 | 2 | 5 |
| Proficient Rx LPUnited States | tablet | ANDAANDA215723 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA088088 | 2 | 0 |
| Oceanside Pharmaceuticals. | tablet | NDANDA012093 | 2 | 0 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA211290 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA215723 | 1 | 1 |
Bulk ingredient listings
- Dipharma Francis SrlItaly · 2 NDC
Enquiry
Common questions
- Who makes isosorbide dinitrate?
- 18 companies list isosorbide dinitrate as a human prescription drug in the openFDA NDC Directory, led by Zydus Lifesciences Limited, Par Health USA, LLC, Zydus Pharmaceuticals USA Inc., Advagen Pharma Limited, BluePoint Laboratories Inc.. 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 isosorbide dinitrate?
- 17 companies list isosorbide dinitrate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies isosorbide dinitrate active ingredient?
- 1 company lists isosorbide dinitrate as a bulk ingredient, including Dipharma Francis Srl.