HydrALAZINE Hydrochloride
- Product NDC
- 76282-310
- 11-digit product format
- 762820310
- Labeler code
- 76282
- Product ID
- 76282-310_f313fc00-1f7a-40ea-9d61-29c4bfba2426
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HydrALAZINE Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals Inc.
- Application
- ANDA090255
- Marketing category
- ANDA
- Marketing start
- 2016-05-20
- 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 | 905199, 905222, 905225, 905395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-310-01 | HydrALAZINE Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 76282-310-10 | HydrALAZINE Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-310 | HYDRALAZINE HYDROCHLORIDE TABLET [EXELAN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20200905_811831f9-a844-463a-874d-fb8407659f0b.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 |
|---|
| 76282-310-01 | 76282031001 | 100 TABLET in 1 BOTTLE (76282-310-01) | 100 tablet | 2016-05-20 | 0000-00-00 | No | No | Current |
| 76282-310-10 | 76282031010 | 1000 TABLET in 1 BOTTLE (76282-310-10) | 1000 tablet | 2016-05-20 | 0000-00-00 | No | No | Current |