Hydralazine Hydrochloride
- Product NDC
- 67046-1520
- 11-digit product format
- 670461520
- Labeler code
- 67046
- Product ID
- 67046-1520_2e96a363-6799-774a-e063-6394a90aac75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA040858
- Marketing category
- ANDA
- Marketing start
- 2025-02-20
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905199 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1520-3 | Hydralazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1520 | HYDRALAZINE HYDROCHLORIDE TABLET [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250223_2e9688ef-781c-aead-e063-6294a90a7bca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1520-3 | 67046152003 | 30 TABLET in 1 BLISTER PACK (67046-1520-3) | 30 tablet | 2025-02-20 | No | No | Historical |