Prescription drug · ANDA
Irbesartan NDC 50228-160
Irbesartan 75 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-160-05 | 50228016005 | 500 TABLET in 1 BOTTLE (50228-160-05)Marketed from Dec 7, 2015 | |
| 50228-160-30 | 50228016030 | 30 TABLET in 1 BOTTLE (50228-160-30)Marketed from Dec 7, 2015 |
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 — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204774
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50228-160_ba124fb5-fa8b-be15-e053-2a95a90ab560SPL ID ba124fb5-fa8b-be15-e053-2a95a90ab560SPL set ID ddca7d7c-07fe-4df6-83ae-a9c05048b66eRxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0350228160308, 0350228160056, 0350228161305, 0350228162302, 0350228161107
- 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
N450228016005followed by a unit qualifier and the quantityPackage 50228-0160-05. 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
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 is 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 of antihyperte…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204774
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 150 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-161 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-162 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-160 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-161 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-162 |