IRBESARTAN
- Product NDC
- 62135-978
- 11-digit product format
- 621350978
- Labeler code
- 62135
- Product ID
- 62135-978_352d8ab7-2e21-869d-e063-6294a90ab91f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA077205
- Marketing category
- ANDA
- Marketing start
- 2012-11-14
- Substance
- IRBESARTAN
- Active strength
- 300 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 | 300 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 |
|---|
| 62135-978-30 | IRBESARTAN | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 62135-978-90 | IRBESARTAN | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-978 | IRBESARTAN TABLET [CHARTWELL RX, LLC] | 3 | Current NDC, 2 package rows | 20250516_6eb0cb56-2e51-45ef-9fd5-5646cf9f78a3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-978-30 | 62135097830 | 30 TABLET in 1 BOTTLE (62135-978-30) | 30 tablet | 2025-05-06 | No | No | Current |
| 62135-978-90 | 62135097890 | 90 TABLET in 1 BOTTLE (62135-978-90) | 90 tablet | 2025-05-01 | No | No | Current |