Irbesartan
- Product NDC
- 70518-2245
- 11-digit product format
- 705182245
- Labeler code
- 70518
- Product ID
- 70518-2245_4dd9566d-b475-20f9-e063-6394a90afe02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202910
- Marketing category
- ANDA
- Marketing start
- 2019-08-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irbesartan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRBESARTAN | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J0E2756Z7N |
| Rxcui | 200095 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2245-0 | Irbesartan | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2245 | IRBESARTAN TABLET [REMEDYREPACK INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250309_0c1fc197-c2d9-453c-b79f-b53de89c188b.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 |
|---|
| 70518-2245-0 | 70518224500 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2245-0) | 90 tablet | 2019-08-01 | 0000-00-00 | No | No | Current |