Amlodipine and Atorvastatin
- Product NDC
- 71335-3076
- 11-digit product format
- 713353076
- Labeler code
- 71335
- Product ID
- 71335-3076_1e0577ab-3a32-4752-b948-ccc25c7c5356
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine and Atorvastatin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
| ATORVASTATIN CALCIUM TRIHYDRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H, 48A5M73Z4Q |
| Rxcui | 597987 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-3076-1 | Amlodipine and Atorvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-3076-1 | 71335307601 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3076-1) | 2026-02-12 | No | No | Historical |