Hydralazine Hydrochloride
- Product NDC
- 70518-4022
- 11-digit product format
- 705184022
- Labeler code
- 70518
- Product ID
- 70518-4022_3f908b4b-ad9d-0995-e063-6394a90a7cf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040858
- Marketing category
- ANDA
- Marketing start
- 2024-02-13
- 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 |
|---|
| 70518-4022-0 | Hydralazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 5 |
| 70518-4022-1 | Hydralazine Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4022 | HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20250509_a70d20d6-23f0-477e-915c-678a86782175.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 |
|---|
| 70518-4022-0 | 70518402200 | 30 TABLET in 1 BLISTER PACK (70518-4022-0) | 30 tablet | 2024-02-13 | No | No | Current |
| 70518-4022-1 | 70518402201 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4022-1) | 90 tablet | 2025-09-20 | No | No | Current |