Atorvastatin Calcium
- Product NDC
- 68180-638
- 11-digit product format
- 681800638
- Labeler code
- 68180
- Product ID
- 68180-638_ab716c10-785b-4d43-a5f0-59f95b0b78c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA204991
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- Substance
- ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 80 mg/1
- Pharmacologic classes
- 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
- Atorvastatin Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | 80 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 |
|---|
| 68180-638-02 | Atorvastatin Calcium | 500 in 1 BOTTLE | TABLET | 500 | | 17 |
| 68180-638-06 | Atorvastatin Calcium | 30 in 1 BOTTLE | TABLET | 30 | | 17 |
| 68180-638-09 | Atorvastatin Calcium | 90 in 1 BOTTLE | TABLET | 90 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-638 | ATORVASTATIN CALCIUM TABLET [LUPIN PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 3 package rows | 20231216_a5767370-15a2-45e5-b980-7af9523aea7b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-638-02 | 68180063802 | 500 TABLET in 1 BOTTLE (68180-638-02) | 500 tablet | 2020-09-24 | 0000-00-00 | No | No | Current |
| 68180-638-06 | 68180063806 | 30 TABLET in 1 BOTTLE (68180-638-06) | 30 tablet | 2020-09-24 | 0000-00-00 | No | No | Current |
| 68180-638-09 | 68180063809 | 90 TABLET in 1 BOTTLE (68180-638-09) | 90 tablet | 2020-09-24 | 0000-00-00 | No | No | Current |