Bisoprolol Fumarate
- Product NDC
- 65862-087
- 11-digit product format
- 658620087
- Labeler code
- 65862
- Product ID
- 65862-087_bb3ee6c5-1c46-41c6-890b-d775a103111a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077910
- Marketing category
- ANDA
- Marketing start
- 2006-12-27
- 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 |
|---|
| 65862-087-01 | Bisoprolol Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 65862-087-30 | Bisoprolol Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BISOPROLOL FUMARATE | ACTIVE INGREDIENT | UR59KN573L | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| BISOPROLOL | ACTIVE MOIETY | Y41JS2NL6U | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-087 | BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240606_2564646d-183c-4759-8726-155a4c22aa2b.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 |
|---|
| 65862-087-01 | 65862008701 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-087-01) | 2006-12-27 | 0000-00-00 | No | No | Current |
| 65862-087-30 | 65862008730 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-087-30) | 2006-12-27 | 0000-00-00 | No | No | Current |
| 65862-087-81 | 65862008781 | 8000 TABLET, FILM COATED in 1 BAG (65862-087-81) | 27-DEC-06 | | | | Current |