Irbesartan
- Product NDC
- 69367-121
- 11-digit product format
- 693670121
- Labeler code
- 69367
- Product ID
- 69367-121_4f0ce3cf-9eb2-40fe-8f3d-cf9228935c45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA204774
- Marketing category
- ANDA
- Marketing start
- 2016-02-01
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN
- Active strength
- 300 mg/300mg
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 69367-121-01 | 69367012101 | 30 mg in 1 BOTTLE (69367-121-01) | 30 mg | 2016-02-01 | 0000-00-00 | No | No | Current |
| 69367-121-03 | 69367012103 | 90 mg in 1 BOTTLE (69367-121-03) | 90 mg | 2016-02-01 | 0000-00-00 | No | No | Current |