Prescription drug · ANDA
Bisoprolol Fumarate and Hydrochlorothiazide NDC 70954-413
Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-413-10 | 70954041310 | 30 TABLET in 1 BOTTLE (70954-413-10)Marketed from Nov 4, 2021 | |
| 70954-413-30 | 70954041330 | 100 TABLET in 1 BOTTLE (70954-413-30)Marketed from Nov 4, 2021 | |
| 70954-413-40 | 70954041340 | 500 TABLET in 1 BOTTLE (70954-413-40)Marketed from Nov 4, 2021 |
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 — 5 mg/1Hydrochlorothiazide — 6.25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215562
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 70954-413_42e66131-cd9a-463a-9e42-260ac2222e3dSPL ID 42e66131-cd9a-463a-9e42-260ac2222e3dSPL set ID a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82cRxCUI 854908, 854916, 854919UNII UR59KN573L, 0J48LPH2THUPC 0370954413301, 0370954412304, 0370954414100, 0370954412106
- 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
N470954041310followed by a unit qualifier and the quantityPackage 70954-0413-10. 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 & 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 215562
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 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-741 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-412 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-414 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-740 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-742 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6413 |