Atorvastatin Calcium
- Product NDC
- 59651-608
- 11-digit product format
- 596510608
- Labeler code
- 59651
- Product ID
- 59651-608_b9128b7d-1e45-4f05-9f0a-26bd825e402d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA217118
- Marketing category
- ANDA
- Marketing start
- 2024-02-13
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 40 mg/1
- Pharmacologic classes
- 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
- Atorvastatin Calcium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 48A5M73Z4Q |
| Rxcui | 259255, 617310, 617311, 617312 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-608-05 | Atorvastatin Calcium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 59651-608-30 | Atorvastatin Calcium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 59651-608-90 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 59651-608-99 | Atorvastatin Calcium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-608 | ATORVASTATIN CALCIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 4 package rows | 20240426_536b5e0d-1bb9-4c9d-a588-460d7647308b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-608-05 | 59651060805 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-608-05) | 2024-02-13 | No | No | Historical |
| 59651-608-30 | 59651060830 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-608-30) | 2024-02-13 | No | No | Historical |
| 59651-608-90 | 59651060890 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-608-90) | 2024-02-13 | No | No | Historical |
| 59651-608-99 | 59651060899 | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-608-99) | 2024-02-13 | No | No | Historical |