Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 71335-1769
- 11-digit product format
- 713351769
- Labeler code
- 71335
- Product ID
- 71335-1769_6449b740-cd61-4a80-93f3-a25cf866a739
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212678
- Marketing category
- ANDA
- Marketing start
- 2019-04-30
- 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
- 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 | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UR59KN573L, 0J48LPH2TH |
| Rxcui | 854919 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1769-1 | Bisoprolol Fumarate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 104 |
| 71335-1769-2 | Bisoprolol Fumarate and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 104 |
| 71335-1769-3 | Bisoprolol Fumarate and Hydrochlorothiazide | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 104 |
| 71335-1769-4 | Bisoprolol Fumarate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1769 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 4 package rows | 20240502_154cb1d2-9fb2-4c8d-90de-6a8062a8d1ba.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 |
|---|
| 71335-1769-1 | 71335176901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1769-1) | 2021-02-02 | 0000-00-00 | No | No | Current |
| 71335-1769-2 | 71335176902 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1769-2) | 2021-12-29 | 0000-00-00 | No | No | Current |
| 71335-1769-3 | 71335176903 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1769-3) | 2021-12-29 | 0000-00-00 | No | No | Current |
| 71335-1769-4 | 71335176904 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1769-4) | 2024-04-05 | | No | No | Historical |