Irbesartan
- Product NDC
- 68180-410
- 11-digit product format
- 681800410
- Labeler code
- 68180
- Product ID
- 68180-410_58ed0a7a-78d3-47e3-95f6-ee4d1dd128bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA201531
- Marketing category
- ANDA
- Marketing start
- 2012-10-23
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN
- Active strength
- 75 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-410-06 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 17 |
| 68180-410-09 | Irbesartan | 90 in 1 BOTTLE | TABLET | 90 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IRBESARTAN | ACTIVE INGREDIENT | J0E2756Z7N | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| IRBESARTAN | ACTIVE MOIETY | J0E2756Z7N | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-410 | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 17 | Legacy NDC, 2 package rows | 20231129_a7c093c2-3eef-4956-8a14-c36aada0304f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-410-06 | 68180041006 | 30 TABLET in 1 BOTTLE (68180-410-06) | 30 tablet | 2012-10-23 | 0000-00-00 | No | No | Current |
| 68180-410-09 | 68180041009 | 90 TABLET in 1 BOTTLE (68180-410-09) | 90 tablet | 2012-10-23 | 0000-00-00 | No | No | Current |