Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 68462-878
- 11-digit product format
- 684620878
- Labeler code
- 68462
- Product ID
- 68462-878_6154a348-821d-46cc-a830-ac5684f9525a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA215995
- Marketing category
- ANDA
- Marketing start
- 2022-01-26
- Substance
- BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
- Active strength
- 2.5; 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bisoprolol Fumarate and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BISOPROLOL FUMARATE | 2.5 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 |
|---|
| 68462-878-01 | Bisoprolol Fumarate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 68462-878-05 | Bisoprolol Fumarate and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 68462-878-30 | Bisoprolol Fumarate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-878 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240124_ab73a6d8-2e33-4fdc-a896-6c68ab772da6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-878-01 | 68462087801 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-878-01) | 2022-01-26 | 0000-00-00 | No | No | Current |
| 68462-878-05 | 68462087805 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-878-05) | 2022-01-26 | 0000-00-00 | No | No | Current |
| 68462-878-30 | 68462087830 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-878-30) | 2022-01-26 | 0000-00-00 | No | No | Current |