Irbesartan
- Product NDC
- 68180-411
- 11-digit product format
- 681800411
- Labeler code
- 68180
- Product ID
- 68180-411_22c8bdba-6c34-485a-af89-3aafd7fd8605
- 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
- Substance
- IRBESARTAN
- Active strength
- 150 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRBESARTAN | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200094, 200095, 200096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-411-02 | Irbesartan | 500 in 1 BOTTLE | TABLET | 500 | | 17 |
| 68180-411-06 | Irbesartan | 30 in 1 BOTTLE | TABLET | 30 | | 17 |
| 68180-411-09 | 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 |
|---|
| 68180-411 | IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 3 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 |
|---|
| 68180-411-02 | 68180041102 | 500 TABLET in 1 BOTTLE (68180-411-02) | 500 tablet | 2012-10-23 | 0000-00-00 | No | No | Current |
| 68180-411-06 | 68180041106 | 30 TABLET in 1 BOTTLE (68180-411-06) | 30 tablet | 2012-10-23 | 0000-00-00 | No | No | Current |
| 68180-411-09 | 68180041109 | 90 TABLET in 1 BOTTLE (68180-411-09) | 90 tablet | 2012-10-23 | 0000-00-00 | No | No | Current |