atorvastatin calcium

Generic: atorvastatin calcium

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium propylene glycol solvate 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-474
Product ID 43063-474_36b13f6a-2c48-ad21-e063-6394a90a51c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090548
Listing Expiration 2026-12-31
Marketing Start 2012-05-29

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 43063474
Hyphenated Format 43063-474

Supplemental Identifiers

RxCUI
617312
UPC
0343063474303
UNII
YRZ789OWMI

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 ANDA090548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-474-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-474-90)
source: ndc

Packages (2)

43063-474-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-474-30) 43063-474-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-474-90)

Ingredients (1)

atorvastatin calcium propylene glycol solvate (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": "36b13f6a-2c48-ad21-e063-6394a90a51c5", "openfda": {"upc": ["0343063474303"], "unii": ["YRZ789OWMI"], "rxcui": ["617312"], "spl_set_id": ["09c6c750-ae05-459f-83e8-4a9e4fd85212"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-474-30)", "package_ndc": "43063-474-30", "marketing_start_date": "20120529"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-474-90)", "package_ndc": "43063-474-90", "marketing_start_date": "20120529"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "43063-474_36b13f6a-2c48-ad21-e063-6394a90a51c5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "43063-474", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE", "strength": "10 mg/1"}], "application_number": "ANDA090548", "marketing_category": "ANDA", "marketing_start_date": "20120529", "listing_expiration_date": "20261231"}