Irbesartan
- Product NDC
- 68382-301
- 11-digit product format
- 683820301
- Labeler code
- 68382
- Product ID
- 68382-301_3d8cb010-c629-4de6-9bb1-caaa7463e37c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA079213
- Marketing category
- ANDA
- Marketing start
- 2017-12-08
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-301-05 | 68382030105 | 500 TABLET in 1 BOTTLE (68382-301-05) | 500 tablet | 2017-12-08 | 0000-00-00 | No | No | Current |
| 68382-301-06 | 68382030106 | 30 TABLET in 1 BOTTLE (68382-301-06) | 30 tablet | 2017-12-08 | 0000-00-00 | No | No | Current |
| 68382-301-10 | 68382030110 | 1000 TABLET in 1 BOTTLE (68382-301-10) | 1000 tablet | 2017-12-08 | 0000-00-00 | No | No | Current |
| 68382-301-16 | 68382030116 | 90 TABLET in 1 BOTTLE (68382-301-16) | 90 tablet | 2017-12-08 | 0000-00-00 | No | No | Current |
| 68382-301-77 | 68382030177 | 10 BLISTER PACK in 1 CARTON (68382-301-77) > 10 TABLET in 1 BLISTER PACK (68382-301-30) | 10 blister pack | 2017-12-08 | 0000-00-00 | No | No | Current |