BISOPROLOL FUMARATE
- Product NDC
- 70095-019
- 11-digit product format
- 700950019
- Labeler code
- 70095
- Product ID
- 70095-019_6ce4dc4f-ad08-424e-b90d-400de0b7050a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BISOPROLOL FUMARATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries Limited
- Application
- ANDA217617
- Marketing category
- ANDA
- Marketing start
- 2024-03-10
- Substance
- BISOPROLOL FUMARATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BISOPROLOL FUMARATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UR59KN573L |
| Rxcui | 854901, 854905 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70095-019-01 | BISOPROLOL FUMARATE | 30 in 1 BOTTLE, UNIT-DOSE | TABLET, FILM COATED | 30 | | 3 |
| 70095-019-02 | BISOPROLOL FUMARATE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70095-019 | BISOPROLOL FUMARATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | Current NDC, 2 package rows | 20241106_7556f457-c4d3-49d6-b383-0ade6d489091.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70095-019-01 | 70095001901 | 30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-019-01) | 2024-03-10 | No | No | Current |
| 70095-019-02 | 70095001902 | 100 TABLET, FILM COATED in 1 BOTTLE (70095-019-02) | 2024-03-10 | No | No | Current |