Hydralazine Hydrochloride
- Product NDC
- 33342-376
- 11-digit product format
- 333420376
- Labeler code
- 33342
- Product ID
- 33342-376_f9f56326-6d72-47d3-89ac-3625b8a6d713
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA211010
- Marketing category
- ANDA
- Marketing start
- 2024-08-26
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905199, 905222, 905225, 905395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-376-11 | Hydralazine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 33342-376-12 | Hydralazine Hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 1 |
| 33342-376-12 | Hydralazine Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
| 33342-376-44 | Hydralazine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-376 | HYDRALAZINE HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20240907_f9f56326-6d72-47d3-89ac-3625b8a6d713.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 |
|---|
| 33342-376-11 | 33342037611 | 100 TABLET in 1 BOTTLE (33342-376-11) | 100 tablet | 2024-08-26 | No | No | Current |
| 33342-376-12 | 33342037612 | 10 BLISTER PACK in 1 CARTON (33342-376-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-08-26 | No | No | Current |
| 33342-376-44 | 33342037644 | 1000 TABLET in 1 BOTTLE (33342-376-44) | 1000 tablet | 2024-08-26 | No | No | Current |