Irbesartan
- Product NDC
- 70518-1690
- 11-digit product format
- 705181690
- Labeler code
- 70518
- Product ID
- 70518-1690_4961546d-44ed-5dab-e063-6394a90a3cde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203071
- Marketing category
- ANDA
- Marketing start
- 2018-11-23
- 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
- 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 |
|---|
| 70518-1690-0 | Irbesartan | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 10 |
| 70518-1690-1 | Irbesartan | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1690 | IRBESARTAN TABLET [REMEDYREPACK INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250227_029a90b6-0722-49be-8400-3ec29526aafd.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 |
|---|
| 70518-1690-0 | 70518169000 | 90 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 70518-1690-1 | 70518169001 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1690-1) | 90 tablet | 2023-04-19 | No | No | Historical |