Irbesartan
- Product NDC
- 0955-1040
- 11-digit product format
- 009551040
- Labeler code
- 0955
- Product ID
- 0955-1040_5236a5fb-5969-4cc2-bcd1-400e261fbf46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- irbesartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Winthrop U.S.
- Application
- NDA020757
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-09-30
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN
- Active strength
- 75 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0955-1040-90 | 00955104090 | 90 TABLET, FILM COATED in 1 BOTTLE (0955-1040-90) | 2019-09-30 | 0000-00-00 | No | No | Current |