Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 70954-414
- 11-digit product format
- 709540414
- Labeler code
- 70954
- Product ID
- 70954-414_394da62e-fb31-4d2b-9ca3-3f6dc2d04013
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA215562
- Marketing category
- ANDA
- Marketing start
- 2021-11-04
- Substance
- BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
- Active strength
- 10; 6.25 mg/1; mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bisoprolol Fumarate and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BISOPROLOL FUMARATE | 10 mg/1 |
| HYDROCHLOROTHIAZIDE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, UR59KN573L |
| Rxcui | 854908, 854916, 854919 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-414-10 | Bisoprolol Fumarate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 70954-414-30 | Bisoprolol Fumarate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 70954-414-40 | Bisoprolol Fumarate and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-414 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [ANI PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240322_a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c.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 |
|---|
| 70954-414-10 | 70954041410 | 30 TABLET in 1 BOTTLE (70954-414-10) | 30 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |
| 70954-414-30 | 70954041430 | 100 TABLET in 1 BOTTLE (70954-414-30) | 100 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |
| 70954-414-40 | 70954041440 | 500 TABLET in 1 BOTTLE (70954-414-40) | 500 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |