Prescription drug · ANDA
bisoprolol fumarate and hydrochlorothiazide NDC 71335-0595
Hydrochlorothiazide 6.25 mg/1; Bisoprolol fumarate 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0595-1 | 71335059501 | 30 TABLET in 1 BOTTLE, PLASTIC (71335-0595-1)Marketed from Jun 25, 2018 | |
| 71335-0595-2 | 71335059502 | 90 TABLET in 1 BOTTLE, PLASTIC (71335-0595-2)Marketed from Mar 19, 2019 | |
| 71335-0595-3 | 71335059503 | 28 TABLET in 1 BOTTLE, PLASTIC (71335-0595-3)Marketed from May 23, 2024 | |
| 71335-0595-4 | 71335059504 | 100 TABLET in 1 BOTTLE, PLASTIC (71335-0595-4)Marketed from Jul 19, 2023 |
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
- Hydrochlorothiazide — 6.25 mg/1Bisoprolol fumarate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079106
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71335-0595_83e47e72-5cf3-4db5-902e-20d7d9595cb9SPL ID 83e47e72-5cf3-4db5-902e-20d7d9595cb9SPL set ID 447c11b6-72fe-418e-a2db-5d90b5347796RxCUI 854919UNII 0J48LPH2TH, UR59KN573L
- 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
N471335059501followed by a unit qualifier and the quantityPackage 71335-0595-01. 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 079106
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 | Hydrochlorothiazide 6.25 mg/1; Bisoprolol fumarate 2.5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-187 |
| bisoprolol fumarate and hydrochlorothiazide | Hydrochlorothiazide 6.25 mg/1; Bisoprolol fumarate 5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-188 |
| bisoprolol fumarate and hydrochlorothiazide | Hydrochlorothiazide 6.25 mg/1; Bisoprolol fumarate 10 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-189 |
| bisoprolol fumarate and hydrochlorothiazide | Hydrochlorothiazide 6.25 mg/1; Bisoprolol fumarate 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1161 |