Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 70954-413
- 11-digit product format
- 709540413
- Labeler code
- 70954
- Product ID
- 70954-413_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
- 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 |
|---|---|
| BISOPROLOL FUMARATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 6.25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | UR59KN573L, 0J48LPH2TH |
| Rxcui | 854908, 854916, 854919 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70954-413-10 | Bisoprolol Fumarate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 70954-413-30 | Bisoprolol Fumarate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 70954-413-40 | Bisoprolol Fumarate and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET | 500 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70954-413-10 | EA - Each | 70954-413 | 19833a29-4a14-4635-9fbe-2b5349a98efc | 1 | 2022-01-06 |
| 70954-413-30 | EA - Each | 70954-413 | 73caf10a-9187-40c4-931d-d6c1921fa20d | 1 | 2022-01-06 |
| 70954-413-40 | EA - Each | 70954-413 | fda41e2c-c3a9-4664-957c-d3f6f107c91e | 1 | 2022-01-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 854908 | bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet | PSN | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854916 | bisoprolol fumarate 2.5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet | PSN | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854919 | bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet | PSN | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854908 | bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral Tablet | SCD | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854916 | bisoprolol fumarate 2.5 MG / hydrochlorothiazide 6.25 MG Oral Tablet | SCD | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854919 | bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral Tablet | SCD | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854908 | bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral Tablet | SY | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854916 | bisoprolol fumarate 2.5 MG / HCTZ 6.25 MG Oral Tablet | SY | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854919 | bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral Tablet | SY | df881501-42ae-624a-e053-2995a90ab2a0 | 4 |
| 854908 | bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet | PSN | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854916 | bisoprolol fumarate 2.5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet | PSN | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854919 | bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet | PSN | 90bb2207-2eaf-495b-a222-c69d4db9e7a3 | 3 |
| 854919 | bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet | PSN | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854908 | bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral Tablet | SCD | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854916 | bisoprolol fumarate 2.5 MG / hydrochlorothiazide 6.25 MG Oral Tablet | SCD | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854919 | bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral Tablet | SCD | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854919 | bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral Tablet | SCD | 90bb2207-2eaf-495b-a222-c69d4db9e7a3 | 3 |
| 854908 | bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral Tablet | SY | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854916 | bisoprolol fumarate 2.5 MG / HCTZ 6.25 MG Oral Tablet | SY | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854919 | bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral Tablet | SY | a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c | 3 |
| 854919 | bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral Tablet | SY | 90bb2207-2eaf-495b-a222-c69d4db9e7a3 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70954-413-10 | 70954041310 | 30 TABLET in 1 BOTTLE (70954-413-10) | 30 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |
| 70954-413-30 | 70954041330 | 100 TABLET in 1 BOTTLE (70954-413-30) | 100 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |
| 70954-413-40 | 70954041340 | 500 TABLET in 1 BOTTLE (70954-413-40) | 500 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |