Bisoprolol Fumarate
- Product NDC
- 29300-127
- 11-digit product format
- 293000127
- Labeler code
- 29300
- Product ID
- 29300-127_958d523d-b040-4475-ad89-6278e5cf0f60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA078635
- Marketing category
- ANDA
- Marketing start
- 2009-09-21
- 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 |
|---|
| 29300-127-01 | Bisoprolol Fumarate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 11 |
| 29300-127-05 | Bisoprolol Fumarate | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 11 |
| 29300-127-13 | Bisoprolol Fumarate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BISOPROLOL FUMARATE | ACTIVE INGREDIENT | UR59KN573L | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| BISOPROLOL | ACTIVE MOIETY | Y41JS2NL6U | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | |
| BISOPROLOL FUMARATE | ACTIVE INGREDIENT | UR59KN573L | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| BISOPROLOL | ACTIVE MOIETY | Y41JS2NL6U | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-127 | BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20221029_4f20df45-3f9c-4a91-b394-e93a08111ec3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 29300-127-01 | 29300012701 | 100 TABLET in 1 BOTTLE, PLASTIC (29300-127-01) | 100 tablet | 2009-09-21 | 0000-00-00 | No | No | Current |
| 29300-127-05 | 29300012705 | 500 TABLET in 1 BOTTLE, PLASTIC (29300-127-05) | 500 tablet | 2016-08-19 | 0000-00-00 | No | No | Current |
| 29300-127-13 | 29300012713 | 30 TABLET in 1 BOTTLE, PLASTIC (29300-127-13) | 30 tablet | 2009-09-21 | 0000-00-00 | No | No | Current |