Hydralazine Hydrochloride
- Product NDC
- 67544-657
- 11-digit product format
- 675440657
- Labeler code
- 67544
- Product ID
- 67544-657_b08e0b2c-c3c7-42f4-a43c-5eb32ce5be79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA088467
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- 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 | 905225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67544-657-60 | Hydralazine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 67544-657-80 | Hydralazine Hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
| 67544-657-92 | Hydralazine Hydrochloride | 270 in 1 BOTTLE | TABLET | 270 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-657 | HYDRALAZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20171222_bfbd5960-ae6b-46f5-adfa-e330d7a21dfa.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 |
|---|
| 67544-657-60 | 67544065760 | 90 TABLET in 1 BOTTLE (67544-657-60) | 90 tablet | 2010-06-21 | 0000-00-00 | No | No | Current |
| 67544-657-80 | 67544065780 | 180 TABLET in 1 BOTTLE (67544-657-80) | 180 tablet | 2015-12-07 | 0000-00-00 | No | No | Current |
| 67544-657-92 | 67544065792 | 270 TABLET in 1 BOTTLE (67544-657-92) | 270 tablet | 2015-11-17 | 0000-00-00 | No | No | Current |