HydrALAZINE Hydrochloride
- Product NDC
- 43353-205
- 11-digit product format
- 433530205
- Labeler code
- 43353
- Product ID
- 43353-205_7ff2351c-0271-49c1-b5d4-cb73b76a508c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HydrALAZINE Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090255
- Marketing category
- ANDA
- Marketing start
- 2016-05-20
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-205-05 | HydrALAZINE Hydrochloride | 4200 in 1 BOTTLE | TABLET | 4200 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-205 | HYDRALAZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20160714_921c8693-84c2-4313-a2a6-ab3be637d554.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 |
|---|
| 43353-205-05 | 43353020505 | 4200 TABLET in 1 BOTTLE (43353-205-05) | 4200 tablet | 2016-07-09 | 0000-00-00 | No | No | Current |