Irbesartan and Hydrochlorothiazide
- Product NDC
- 70518-1386
- 11-digit product format
- 705181386
- Labeler code
- 70518
- Product ID
- 70518-1386_c2875fd5-0b1b-5c59-e053-2995a90a5ea8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090351
- Marketing category
- ANDA
- Marketing start
- 2018-08-27
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1386-0 | 70518138600 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1386-0) | 90 tablet | 2018-08-27 | 0000-00-00 | No | No | Current |