atorvastatin calcium

Generic: atorvastatin calcium

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

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler qpharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 20 mg/1

Manufacturer
QPharma, Inc.

Identifiers & Regulatory

Product NDC 42708-004
Product ID 42708-004_45b41a94-e930-c847-e063-6394a90ad348
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205300
Listing Expiration 2026-12-31
Marketing Start 2017-05-04

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 42708004
Hyphenated Format 42708-004

Supplemental Identifiers

RxCUI
617310 617311 617312
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 (source: ndc)
Application Number ANDA205300 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42708-004-30)
source: ndc

Packages (1)

42708-004-30 30 TABLET, FILM COATED in 1 BOTTLE (42708-004-30)

Ingredients (1)

atorvastatin calcium trihydrate (20 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": "45b41a94-e930-c847-e063-6394a90ad348", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["617310", "617311", "617312"], "spl_set_id": ["3e59aa97-5480-41e0-86b0-047e648b976d"], "manufacturer_name": ["QPharma, Inc."]}, "finished": true, "packaging": [{"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42708-004-30)", "package_ndc": "42708-004-30", "marketing_start_date": "20180531"}], "brand_name": "Atorvastatin Calcium", "product_id": "42708-004_45b41a94-e930-c847-e063-6394a90ad348", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "42708-004", "generic_name": "Atorvastatin Calcium", "labeler_name": "QPharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA205300", "marketing_category": "ANDA", "marketing_start_date": "20170504", "listing_expiration_date": "20261231"}