Prescription drug · ANDA
Bisoprolol Fumarate and Hydrochlorothiazide NDC 68462-878
Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 · Tablet, Film coated · Oral · GLENMARK PHARMACEUTICALS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-878-01 | 68462087801 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-878-01)Marketed from Jan 26, 2022 | |
| 68462-878-05 | 68462087805 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-878-05)Marketed from Jan 26, 2022 | |
| 68462-878-30 | 68462087830 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-878-30)Marketed from Jan 26, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bisoprolol Fumarate and Hydrochlorothiazide
- Generic name (nonproprietary)
- bisoprolol fumarate and hydrochlorothiazide
- Active ingredients
- Bisoprolol fumarate — 2.5 mg/1Hydrochlorothiazide — 6.25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215995
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 68462-878_6154a348-821d-46cc-a830-ac5684f9525aSPL ID 6154a348-821d-46cc-a830-ac5684f9525aSPL set ID ab73a6d8-2e33-4fdc-a896-6c68ab772da6RxCUI 854908, 854916, 854919UNII UR59KN573L, 0J48LPH2THUPC 0368462880302, 0368462879306, 0368462878309
- Pharmacologic class
- Thiazide Diuretic; beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468462087801followed by a unit qualifier and the quantityPackage 68462-0878-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215995
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2616 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7357 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6030 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-879 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-880 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2589 |