Amlodipine and Atorvastatin
- Product NDC
- 71335-2924
- 11-digit product format
- 713352924
- Labeler code
- 71335
- Product ID
- 71335-2924_935246fc-48db-4814-a8ae-e307b9b1f7b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Atorvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205199
- Marketing category
- ANDA
- Marketing start
- 2020-07-29
- Substance
- AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 10; 10 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Amlodipine and Atorvastatin
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
| ATORVASTATIN CALCIUM TRIHYDRATE | 10 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 864V2Q084H, 48A5M73Z4Q |
| Rxcui | 597987 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 864V2Q084H | AMLODIPINE BESYLATE | 111470-99-6 | AMLODIPINE BESYLATE |
| 48A5M73Z4Q | ATORVASTATIN CALCIUM TRIHYDRATE | 344423-98-9 | ATORVASTATIN CALCIUM TRIHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2924-1 | 71335292401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2924-1) | 2025-10-30 | No | No | Historical |