Atorvastatin Calcium
- Product NDC
- 63187-336
- 11-digit product format
- 631870336
- Labeler code
- 63187
- Product ID
- 63187-336_794a3f94-d134-4a99-9c1a-4fe4e0b6103a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atorvastatin Calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA091624
- Marketing category
- ANDA
- Marketing start
- 2013-04-05
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ATORVASTATIN CALCIUM TRIHYDRATE | ACTIVE INGREDIENT | 48A5M73Z4Q | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| ATORVASTATIN | ACTIVE MOIETY | A0JWA85V8F | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | INACTIVE INGREDIENT | 905HNO1SIH | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-336 | ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP] | 4 | Legacy NDC | 20210116_a25666a6-6e45-46c9-8c9e-e693756f940a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-336-30 | 63187033630 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-336-30) | 2018-12-01 | 0000-00-00 | No | No | Current |