Hydralazine Hydrochloride
- Product NDC
- 82868-045
- 11-digit product format
- 828680045
- Labeler code
- 82868
- Product ID
- 82868-045_46dcba1e-2a2e-cfd1-e063-6394a90a19ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA040858
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- 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 |
|---|
| 82868-045-30 | Hydralazine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-045 | HYDRALAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20240302_1275dd50-d97f-2e8f-e063-6394a90a4a67.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 |
|---|
| 82868-045-30 | 82868004530 | 30 TABLET in 1 BOTTLE, PLASTIC (82868-045-30) | 30 tablet | 2024-02-15 | No | No | Historical |