Prescription drug · ANDA
Irbesartan NDC 33342-048
Irbesartan 150 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-048-07 | 33342004807 | 30 TABLET in 1 BOTTLE (33342-048-07)Marketed from Sep 27, 2012 | |
| 33342-048-10 | 33342004810 | 90 TABLET in 1 BOTTLE (33342-048-10)Marketed from Mar 11, 2013 | |
| 33342-048-12 | 33342004812 | 10 BLISTER PACK in 1 CARTON (33342-048-12) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 27, 2012 | |
| 33342-048-15 | 33342004815 | 500 TABLET in 1 BOTTLE (33342-048-15)Marketed from Sep 27, 2012 | |
| 33342-048-65 | 33342004865 | 6800 TABLET in 1 POUCH (33342-048-65)Marketed from Feb 26, 2019 |
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 202254
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 33342-048_5a240405-5eb7-46ca-811b-d8dd93ee43d3SPL ID 5a240405-5eb7-46ca-811b-d8dd93ee43d3SPL set ID e8635a1c-ae06-4e23-99f7-e704f91d6f43RxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0333342049100, 0333342047106, 0333342048103
- 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
N433342004807followed by a unit qualifier and the quantityPackage 33342-0048-07. 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 of …
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 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 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 |
| Irbesartan | Irbesartan 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1263 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-047 |
| Irbesartan | Irbesartan 300 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-049 |
| Irbesartan | Irbesartan 75 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8259 |