Hydralazine Hydrochloride
- Product NDC
- 70518-4352
- 11-digit product format
- 705184352
- Labeler code
- 70518
- Product ID
- 70518-4352_37f097fd-43b5-3c7d-e063-6394a90ae2f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040858
- Marketing category
- ANDA
- Marketing start
- 2025-06-03
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4352-0 | Hydralazine Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 2 |
| 70518-4352-1 | Hydralazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4352-0 | 70518435200 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4352-0) | 90 tablet | 2025-06-03 | No | No | Current |
| 70518-4352-1 | 70518435201 | 30 TABLET in 1 BLISTER PACK (70518-4352-1) | 30 tablet | 2025-06-19 | No | No | Current |