Hydralazine Hydrochloride
- Product NDC
- 70518-3852
- 11-digit product format
- 705183852
- Labeler code
- 70518
- Product ID
- 70518-3852_3f8c1a73-dd59-1bdc-e063-6294a90a54fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205236
- Marketing category
- ANDA
- Marketing start
- 2023-09-03
- 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 |
|---|
| 70518-3852-0 | Hydralazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3852 | HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 2 | Current NDC, 1 package rows | 20240403_0d65e146-83e5-427f-ac06-04c0d8e72cea.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 |
|---|
| 70518-3852-0 | 70518385200 | 30 TABLET in 1 BLISTER PACK (70518-3852-0) | 30 tablet | 2023-09-03 | No | No | Historical |