IRBESARTAN
- Product NDC
- 42658-122
- 11-digit product format
- 426580122
- Labeler code
- 42658
- Product ID
- 42658-122_422e87bf-8271-64d5-e063-6294a90a63ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRBESARTAN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hisun Pharmaceuticals USA Inc.
- Application
- ANDA206194
- Marketing category
- ANDA
- Marketing start
- 2017-04-15
- 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 |
|---|
| 42658-122-01 | IRBESARTAN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 42658-122-04 | IRBESARTAN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 11 |
| 42658-122-07 | IRBESARTAN | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42658-122 | IRBESARTAN TABLET, FILM COATED [HISUN PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20211110_61ab1b6e-c849-49ca-a3f0-150774db649d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42658-122-01 | 42658012201 | 30 TABLET, FILM COATED in 1 BOTTLE (42658-122-01) | 2017-04-15 | 0000-00-00 | No | No | Current |
| 42658-122-04 | 42658012204 | 90 TABLET, FILM COATED in 1 BOTTLE (42658-122-04) | 2017-04-15 | 0000-00-00 | No | No | Current |
| 42658-122-07 | 42658012207 | 500 TABLET, FILM COATED in 1 BOTTLE (42658-122-07) | 2017-04-15 | 0000-00-00 | No | No | Current |