Amlodipine and atorvastatin
- Product NDC
- 0378-4512
- 11-digit product format
- 003784512
- Labeler code
- 0378
- Product ID
- 0378-4512_bd2370c0-0e67-4e93-b4cf-08134ba68346
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and atorvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA200465
- Marketing category
- ANDA
- Marketing start
- 2013-02-14
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 3 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4512-93 | 00378451293 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4512-93) | 2013-02-14 | 0000-00-00 | No | No | Current |