Bisoprolol Fumarate and Hydrochlorothiazide
- Product NDC
- 21695-808
- 11-digit product format
- 216950808
- Labeler code
- 21695
- Product ID
- 21695-808_4ae433f5-52bb-4403-984c-32f0fad50dd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bisoprolol Fumarate and Hydrochlorothiazide
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA075579
- Marketing category
- ANDA
- Marketing start
- 2000-09-25
- Marketing end
- 0000-00-00
- Substance
- BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-808-30 | Bisoprolol Fumarate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| bisoprolol fumarate | ACTIVE INGREDIENT | UR59KN573L | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| hydrochlorothiazide | ACTIVE INGREDIENT | 0J48LPH2TH | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| bisoprolol | ACTIVE MOIETY | Y41JS2NL6U | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| hydrochlorothiazide | ACTIVE MOIETY | 0J48LPH2TH | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-808 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20101220_4ae433f5-52bb-4403-984c-32f0fad50dd1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-808-30 | 21695080830 | 30 in 1 BOTTLE | Historical |