Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 10135-741
- 11-digit product format
- 101350741
- Labeler code
- 10135
- Product ID
- 10135-741_3f7bca13-71ae-c3ed-e063-6294a90ac734
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA215562
- Marketing category
- ANDA
- Marketing start
- 2022-05-01
- 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 |
|---|
| 10135-741-01 | Bisoprolol Fumarate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 10135-741-05 | Bisoprolol Fumarate and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-741 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [MARLEX PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241004_df881501-42ae-624a-e053-2995a90ab2a0.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 |
|---|
| 10135-741-01 | 10135074101 | 100 TABLET in 1 BOTTLE (10135-741-01) | 100 tablet | 2022-05-01 | 0000-00-00 | No | No | Current |
| 10135-741-05 | 10135074105 | 500 TABLET in 1 BOTTLE (10135-741-05) | 500 tablet | 2022-05-01 | 0000-00-00 | No | No | Current |