Hydralazine Hydrochloride
- Product NDC
- 71610-561
- 11-digit product format
- 716100561
- Labeler code
- 71610
- Product ID
- 71610-561_547e8073-67bc-4f54-bcc9-0fb525db6687
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA205236
- Marketing category
- ANDA
- Marketing start
- 2021-03-04
- 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 | 905222, 905225, 905395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-561-60 | Hydralazine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
| 71610-561-80 | Hydralazine Hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 2 |
| 71610-561-92 | Hydralazine Hydrochloride | 270 in 1 BOTTLE | TABLET | 270 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-561 | HYDRALAZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20240410_c2638ae6-a210-490f-8389-bbed6a3229c5.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 |
|---|
| 71610-561-60 | 71610056160 | 90 TABLET in 1 BOTTLE (71610-561-60) | 90 tablet | 2021-05-25 | 0000-00-00 | No | No | Current |
| 71610-561-80 | 71610056180 | 180 TABLET in 1 BOTTLE (71610-561-80) | 180 tablet | 2021-05-25 | 0000-00-00 | No | No | Current |
| 71610-561-92 | 71610056192 | 270 TABLET in 1 BOTTLE (71610-561-92) | 270 tablet | 2021-05-25 | 0000-00-00 | No | No | Current |