Bisoprolol Fumarate Tablets, USP
- Manufacturer
- Zydus Lifesciences Limited
- Effective date
- 2024-08-14
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 21:10:42
Label at a glance#
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BISOPROLOL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 97e4a60d-917d-ef62-dc8a-bd557b62b708 | Product name | 7 | 20260129 |
| 9b303cd4-3186-2454-5706-3137e8b2dfd2 | Product name | 4 | 20221110 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1726-1 | Bisoprolol Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 2 | |
| 70771-1726-3 | Bisoprolol Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 2 | |
| 70771-1727-1 | Bisoprolol Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 2 | |
| 70771-1727-3 | Bisoprolol Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70771-1726 | BISOPROLOL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240817_2d380e61-052c-4c33-8a35-01c9eb651d68.zip |
| 70771-1727 | BISOPROLOL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240817_2d380e61-052c-4c33-8a35-01c9eb651d68.zip |
Products#
Every source-derived product name is available through these pages.
- Bisoprolol Fumarate
- BISOPROLOL
- ALUMINUM OXIDE
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- BUTYLATED HYDROXYANISOLE
- CROSPOVIDONE (12 MPA.S AT 5%)
- D&C YELLOW NO. 10 ALUMINUM LAKE
- FD&C RED NO. 40
- HYPROMELLOSE 2910 (6 MPA.S)
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 6000
- SILICON DIOXIDE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1726 | 70771-1726-3, 70771-1726-1 |
| 70771-1727 | 70771-1727-3, 70771-1727-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215680-001 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | |
| A215680-002 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215680-001 | AB |
| A215680-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215680-001 | BISOPROLOL FUMARATE | 5MG | TABLET / ORAL | AB | 2022-07-25 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215680-002 | BISOPROLOL FUMARATE | 10MG | TABLET / ORAL | AB | 2022-07-25 | ea1830bbd6c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A215680-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A215680-002 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A215680-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A215680-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A215680-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215680-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A215680-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215680-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215680-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215680-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215680-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215680-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215680-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215680-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215680-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215680-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215680-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215680-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215680-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215680-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215680-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215680-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215680-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215680-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215680-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215680-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215680-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215680-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215680-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215680-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215680-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215680-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215680-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215680-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215680-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215680-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215680-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215680-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215680-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215680-002 | AB | 1 | ea1830bbd6c7… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bisoprolol Fumarate | BISOPROLOL FUMARATE | Zydus Lifesciences Limited | 2d380e61-052c-4c33-8a35-01c9eb651d68 | 2024-08-14 | 70771-1727-1 70771-1726-1 70771-1727-3 70771-1726-3 70771-1727 70771-1726 70771172701 70771172603 70771172601 70771172703 bd36cf67-11ab-4a1f-b1b6-9d5c078a9206 2d380e61-052c-4c33-8a35-01c9eb651d68 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

