valsartan and hydrochlorothiazide
- Product NDC
- 68382-283
- 11-digit product format
- 683820283
- Labeler code
- 68382
- Product ID
- 68382-283_84d7e724-d8f9-4ced-9013-b064226d482d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA203000
- Marketing category
- ANDA
- Marketing start
- 2020-02-12
- Marketing end
- 0000-00-00
- Substance
- VALSARTAN; HYDROCHLOROTHIAZIDE
- Active strength
- 320 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
- 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 |
|---|
| 68382-283-10 | 68382028310 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-283-10) | | 2020-02-12 | 0000-00-00 | No | No | Current |
| 68382-283-16 | 68382028316 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-283-16) | | 2020-02-12 | 0000-00-00 | No | No | Current |
| 68382-283-77 | 68382028377 | 10 BLISTER PACK in 1 CARTON (68382-283-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-283-30) | 10 blister pack | 2020-02-12 | 0000-00-00 | No | No | Current |