Prescription drug · ANDA
Bisoprolol Fumarate and Hydrochlorothiazide NDC 71335-1769
Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1769-1 | 71335176901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1769-1)Marketed from Feb 2, 2021 | |
| 71335-1769-2 | 71335176902 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1769-2)Marketed from Dec 29, 2021 | |
| 71335-1769-3 | 71335176903 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1769-3)Marketed from Dec 29, 2021 | |
| 71335-1769-4 | 71335176904 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1769-4)Marketed from Apr 5, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212678
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71335-1769_ea9c351f-371e-43e3-bf46-b127aa0db857SPL ID ea9c351f-371e-43e3-bf46-b127aa0db857SPL set ID 154cb1d2-9fb2-4c8d-90de-6a8062a8d1baRxCUI 854919UNII UR59KN573L, 0J48LPH2TH
- 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
N471335176901followed by a unit qualifier and the quantityPackage 71335-1769-01. 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 & 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 212678
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 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5905 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5849 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Edenbridge Pharmaceuticals LLC. | 42799-922 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Edenbridge Pharmaceuticals LLC. | 42799-920 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Edenbridge Pharmaceuticals LLC. | 42799-921 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1931 |