Prescription drug · ANDA
Irbesartan NDC 71335-1547
Irbesartan 75 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1547-1 | 7133515470171335154701 | 30 TABLET in 1 BOTTLE (71335-1547-1)Marketed from Mar 30, 2020 | |
| 71335-1547-2 | 7133515470271335154702 | 90 TABLET in 1 BOTTLE (71335-1547-2)Marketed from Mar 30, 2020 |
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)
- Irbesartan
- Generic name (nonproprietary)
- irbesartan
- Active ingredients
- Irbesartan — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202910
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-1547_5e412d17-3dc4-4db6-a9fe-c139a289cd58SPL ID 5e412d17-3dc4-4db6-a9fe-c139a289cd58SPL set ID 7e0ddb7b-80c5-47ab-afee-c74bb735e829RxCUI 200094, 200095UNII J0E2756Z7N
- Pharmacologic class
- Angiotensin 2 Receptor 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
N471335154701followed by a unit qualifier and the quantityPackage 71335-1547-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Irbesartan tablet is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled t…
Excerpt only. Read the full label for complete information.
About NDC 71335-1547
- What is NDC 71335-1547?
- 71335-1547 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Irbesartan.
- What is the active ingredient?
- Irbesartan.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Irbesartan?
- 77 other product NDCs are listed under this name. See all Irbesartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Irbesartan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | NorthStar RxLLC | 72603-670 | 72603-0670-01 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | NorthStar RxLLC | 72603-671 | 72603-0671-01 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | NorthStar RxLLC | 72603-672 | 72603-0672-0172603-0672-02 |
| Irbesartan | Irbesartan 75 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-327 | 72205-0327-0572205-0327-0672205-0327-30+2 more |
| Irbesartan | Irbesartan 150 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-328 | 72205-0328-0572205-0328-0672205-0328-10+3 more |
| Irbesartan | Irbesartan 300 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-329 | 72205-0329-0572205-0329-0672205-0329-30+2 more |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | AvKARE | 42291-940 | 42291-0940-90 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | AvKARE | 42291-941 | 42291-0941-90 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | AvKARE | 42291-942 | 42291-0942-90 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Quality Care Products, LLC | 83008-084 | 83008-0084-30 |
Other NDCs under ANDA 202910
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 |
|---|---|---|---|---|
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-729 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-730 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-731 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-1284 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | A-S Medication Solutions | 50090-2017 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | A-S Medication Solutions | 50090-6938 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8670 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2245 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2246 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2685 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Proficient Rx LP | 71205-452 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1244 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1826 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2354 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | direct rx | 72189-201 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | direct rx | 72189-205 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | direct rx | 72189-270 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Quality Care Products, LLC | 83008-084 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Quality Care Products, LLC | 83008-085 |