Prescription drug · ANDA
Irbesartan NDC 63629-8259
Irbesartan 75 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8259-1 | 63629825901 | 30 TABLET in 1 BOTTLE (63629-8259-1)Marketed from Feb 9, 2022 | |
| 63629-8259-2 | 63629825902 | 90 TABLET in 1 BOTTLE (63629-8259-2)Marketed from Feb 9, 2022 |
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 Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202254
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63629-8259_74e1f56c-cdb4-4a47-841a-c4b7f58ad986SPL ID 74e1f56c-cdb4-4a47-841a-c4b7f58ad986SPL set ID ed789dc1-0b39-4efc-990d-7b6b43a8b3baRxCUI 200094UNII 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
N463629825901followed by a unit qualifier and the quantityPackage 63629-8259-01. 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 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 trials o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202254
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 300 mg/1 | TabletOral | NorthStar RxLLC | 72603-672 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1263 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-049 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-047 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-048 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Proficient Rx LP | 71205-379 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Proficient Rx LP | 63187-737 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5241 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | NorthStar RxLLC | 72603-671 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | NorthStar RxLLC | 72603-670 |