Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 70771-1761
- 11-digit product format
- 707711761
- Labeler code
- 70771
- Product ID
- 70771-1761_9d6e36f0-a9e4-4b66-997a-fd5f8e4e1cf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bisoprolol fumarate and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA215666
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- Substance
- BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
- Active strength
- 5; 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 | 5 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 |
|---|
| 70771-1761-1 | Bisoprolol Fumarate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 70771-1761-3 | Bisoprolol Fumarate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 70771-1761-5 | Bisoprolol Fumarate and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1761 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 1 | Current NDC, 3 package rows | 20230301_35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1761-1 | 70771176101 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1761-1) | 2023-03-01 | No | No | Historical |
| 70771-1761-3 | 70771176103 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1761-3) | 2023-03-01 | No | No | Historical |
| 70771-1761-5 | 70771176105 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1761-5) | 2023-03-01 | No | No | Historical |