candesartan cilexetil and hydrochlorothiazide
- Product NDC
- 68382-416
- 11-digit product format
- 683820416
- Labeler code
- 68382
- Product ID
- 68382-416_7750ee73-dc70-452f-87f1-f38216254e35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- candesartan cilexetil and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA203466
- Marketing category
- ANDA
- Marketing start
- 2018-04-14
- Marketing end
- 0000-00-00
- Substance
- CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
- Active strength
- 32 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 |
|---|
| 68382-416-01 | 68382041601 | 100 TABLET in 1 BOTTLE (68382-416-01) | 100 tablet | 2018-04-14 | 0000-00-00 | No | No | Current |
| 68382-416-06 | 68382041606 | 30 TABLET in 1 BOTTLE (68382-416-06) | 30 tablet | 2018-04-14 | 0000-00-00 | No | No | Current |
| 68382-416-10 | 68382041610 | 1000 TABLET in 1 BOTTLE (68382-416-10) | 1000 tablet | 2018-04-14 | 0000-00-00 | No | No | Current |
| 68382-416-16 | 68382041616 | 90 TABLET in 1 BOTTLE (68382-416-16) | 90 tablet | 2018-04-14 | 0000-00-00 | No | No | Current |
| 68382-416-77 | 68382041677 | 10 BLISTER PACK in 1 CARTON (68382-416-77) > 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2018-04-14 | 0000-00-00 | No | No | Current |