Hydralazine Hydrochloride
- Product NDC
- 51079-075
- 11-digit product format
- 510790075
- Labeler code
- 51079
- Product ID
- 51079-075_3a8625af-ede6-2b68-e063-6394a90a4536
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA088467
- Marketing category
- ANDA
- Marketing start
- 2007-12-26
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydralazine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905199, 905225, 905395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51079-075-01 | Hydralazine Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 15 |
| 51079-075-20 | Hydralazine Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-075 | HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20230404_493a8b7e-5bb1-4db2-91a7-77ed87864131.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51079-075-01 | 51079007501 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-075-20 | 51079007520 | 100 BLISTER PACK in 1 CARTON (51079-075-20) / 1 TABLET in 1 BLISTER PACK (51079-075-01) | 100 blister pack | 2007-12-26 | 0000-00-00 | No | No | Current |