Hydralazine Hydrochloride
- Product NDC
- 63629-5424
- 11-digit product format
- 636295424
- Labeler code
- 63629
- Product ID
- 63629-5424_0b952aaa-efd8-4417-ac27-96ae4a777992
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040901
- Marketing category
- ANDA
- Marketing start
- 2010-01-01
- Marketing end
- 0000-00-00
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-5424-1 | 2024-07-24 | C162847 | 48780-1 | 9d75b9d0-875b-f424-e053-dadaa90a57ce | d79eb016-30c0-4d3f-b854-ada5a43fe5f7 |
| 63629-5424-2 | 2024-07-24 | C162847 | 48780-1 | 9d75b9d0-875b-f424-e053-dadaa90a57ce | d79eb016-30c0-4d3f-b854-ada5a43fe5f7 |
| 63629-5424-3 | 2024-07-24 | C162847 | 48780-1 | 9d75b9d0-875b-f424-e053-dadaa90a57ce | d79eb016-30c0-4d3f-b854-ada5a43fe5f7 |
| 63629-5424-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-875b-f424-e053-dadaa90a57ce | d79eb016-30c0-4d3f-b854-ada5a43fe5f7 |
| 63629-5424-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-875b-f424-e053-dadaa90a57ce | d79eb016-30c0-4d3f-b854-ada5a43fe5f7 |
| 63629-5424-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-875b-f424-e053-dadaa90a57ce | d79eb016-30c0-4d3f-b854-ada5a43fe5f7 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | FD171B778Y | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1001 | |
| HYDRALAZINE | ACTIVE MOIETY | 26NAK24LS8 | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1001 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1001 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1001 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1001 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1001 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1001 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-5424 | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1003 | Legacy NDC | 20250327_d79eb016-30c0-4d3f-b854-ada5a43fe5f7.zip |