Amlodipine and atorvastatin
- Product NDC
- 0378-4517
- 11-digit product format
- 003784517
- Labeler code
- 0378
- Product ID
- 0378-4517_bee991e8-1686-425f-95cb-ff8d3133fffa
- 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
- 2014-11-06
- 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 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 | 404011, 404013, 597967, 597977, 597980, 597984, 597987, 597990 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4517-93 | Amlodipine and atorvastatin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| ATORVASTATIN CALCIUM TRIHYDRATE | ACTIVE INGREDIENT | 48A5M73Z4Q | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| ATORVASTATIN | ACTIVE MOIETY | A0JWA85V8F | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| ARGININE | INACTIVE INGREDIENT | 94ZLA3W45F | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4517 | AMLODIPINE AND ATORVASTATIN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 18 | Current NDC, Legacy NDC, 1 package rows | 20250321_4be76756-4114-4d50-a36c-fd410f6c773d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4517-93 | 00378451793 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4517-93) | 2014-11-06 | 0000-00-00 | No | No | Current |