Hydralazine Hydrochloride
- Product NDC
- 63629-8493
- 11-digit product format
- 636298493
- Labeler code
- 63629
- Product ID
- 63629-8493_6cbee232-1810-4489-b081-362d0e41399b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205236
- Marketing category
- ANDA
- Marketing start
- 2017-05-26
- 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 |
|---|
| 63629-8493-1 | Hydralazine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8493 | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 1 package rows | 20240112_4985994c-23ab-4409-bab6-5a17db767f13.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8493-1 | 63629849301 | 1000 TABLET in 1 BOTTLE (63629-8493-1) | 1000 tablet | 2021-05-18 | 0000-00-00 | No | No | Current |