Prescription drug · ANDA
Irbesartan NDC 29300-213
Irbesartan 150 mg/1 · Tablet · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-213-05 | 29300021305 | 500 TABLET in 1 BOTTLE, PLASTIC (29300-213-05)Marketed from Feb 28, 2018 | |
| 29300-213-13 | 29300021313 | 30 TABLET in 1 BOTTLE, PLASTIC (29300-213-13)Marketed from Feb 28, 2018 | |
| 29300-213-19 | 29300021319 | 90 TABLET in 1 BOTTLE, PLASTIC (29300-213-19)Marketed from Feb 28, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203020
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 29300-213_90c9face-5ead-4f4e-81f3-026124b50ba8SPL ID 90c9face-5ead-4f4e-81f3-026124b50ba8SPL set ID fdf196d5-e933-49de-9c4c-bde50149c7d4RxCUI 200094, 200095, 200096UNII 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
N429300021305followed by a unit qualifier and the quantityPackage 29300-0213-05. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 203020
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 | Unichem Pharmaceuticals (USA), Inc. | 29300-214 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-212 |