atorvastatin calcium

Generic: atorvastatin calcium, film coated

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium, film coated
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3546
Product ID 68071-3546_2d3fb96f-feeb-5b60-e063-6394a90a46e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209912
Listing Expiration 2026-12-31
Marketing Start 2018-06-18

Pharmacologic Class

Classes
hmg-coa reductase inhibitor [epc] hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713546
Hyphenated Format 68071-3546

Supplemental Identifiers

RxCUI
617312
UPC
0368071354690
UNII
48A5M73Z4Q

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name atorvastatin calcium (source: ndc)
Generic Name atorvastatin calcium, film coated (source: ndc)
Application Number ANDA209912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (68071-3546-9)
source: ndc

Packages (1)

68071-3546-9 90 TABLET in 1 BOTTLE (68071-3546-9)

Ingredients (1)

atorvastatin calcium trihydrate (10 mg/1)

Linked Drug Pages (1)

atorvastatin calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d3fb96f-feeb-5b60-e063-6394a90a46e8", "openfda": {"upc": ["0368071354690"], "unii": ["48A5M73Z4Q"], "rxcui": ["617312"], "spl_set_id": ["0a9d4e36-305a-2120-e063-6294a90a01bd"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3546-9)", "package_ndc": "68071-3546-9", "marketing_start_date": "20231120"}], "brand_name": "atorvastatin calcium", "product_id": "68071-3546_2d3fb96f-feeb-5b60-e063-6394a90a46e8", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68071-3546", "generic_name": "atorvastatin calcium, film coated", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA209912", "marketing_category": "ANDA", "marketing_start_date": "20180618", "listing_expiration_date": "20261231"}