Telmisartan and Hydrochlorothiazide
- Product NDC
- 68382-514
- 11-digit product format
- 683820514
- Labeler code
- 68382
- Product ID
- 68382-514_cba2a5ed-ad88-490f-b1c8-ee9360af5002
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA204221
- Marketing category
- ANDA
- Marketing start
- 2017-10-12
- Marketing end
- 0000-00-00
- Substance
- HYDROCHLOROTHIAZIDE; TELMISARTAN
- Active strength
- 13 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
- 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 |
|---|
| 68382-514-06 | 68382051406 | 30 TABLET in 1 BOTTLE (68382-514-06) | 30 tablet | 2017-10-12 | 0000-00-00 | No | No | Current |
| 68382-514-16 | 68382051416 | 90 TABLET in 1 BOTTLE (68382-514-16) | 90 tablet | 2017-10-12 | 0000-00-00 | No | No | Current |
| 68382-514-84 | 68382051484 | 3 BLISTER PACK in 1 CARTON (68382-514-84) > 10 TABLET in 1 BLISTER PACK (68382-514-30) | 3 blister pack | 2017-10-12 | 0000-00-00 | No | No | Current |