Amlodipine and atorvastatin
- Product NDC
- 68382-427
- 11-digit product format
- 683820427
- Labeler code
- 68382
- Product ID
- 68382-427_63951023-2bfe-4973-87f2-07b3f5a010fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and atorvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA207762
- Marketing category
- ANDA
- Marketing start
- 2019-05-30
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- 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 |
|---|
| 68382-427-01 | 68382042701 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-427-01) | | 2019-05-30 | 0000-00-00 | No | No | Current |
| 68382-427-06 | 68382042706 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-427-06) | | 2019-05-30 | 0000-00-00 | No | No | Current |
| 68382-427-16 | 68382042716 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-427-16) | | 2019-05-30 | 0000-00-00 | No | No | Current |
| 68382-427-77 | 68382042777 | 10 BLISTER PACK in 1 CARTON (68382-427-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-427-30) | 10 blister pack | 2019-05-30 | 0000-00-00 | No | No | Current |