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 | 6362982590163629825901 | 30 TABLET in 1 BOTTLE (63629-8259-1)Marketed from Feb 9, 2022 | |
| 63629-8259-2 | 6362982590263629825902 | 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 PrepackNDC labeler code 63629
- 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_0792cf42-f3a7-4419-8764-676484921763SPL ID 0792cf42-f3a7-4419-8764-676484921763
- 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 63629-8259
- What is NDC 63629-8259?
- 63629-8259 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 63629. 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 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 75 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-047 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-048 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-049 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Proficient Rx LP | 63187-737 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5241 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Proficient Rx LP | 71205-379 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1263 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | NorthStar RxLLC | 72603-670 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | NorthStar RxLLC | 72603-671 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | NorthStar RxLLC | 72603-672 |