Irbesartan and Hydrochlorothiazide
- Product NDC
- 0955-1046
- 11-digit product format
- 009551046
- Labeler code
- 0955
- Product ID
- 0955-1046_77927e82-289a-450a-ba00-514694d5738b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- irbesartan and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Winthrop U.S.
- Application
- NDA020758
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-09-30
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN; HYDROCHLOROTHIAZIDE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
- 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 |
|---|
| 0955-1046-90 | 00955104690 | 90 TABLET, FILM COATED in 1 BOTTLE (0955-1046-90) | 2019-09-03 | 0000-00-00 | No | No | Current |