atorvastatin calcium

Generic: atorvastatin calcium

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium propylene glycol solvate 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6290
Product ID 0904-6290_71aa6f50-677d-4d87-a990-4f7c91a67c8b
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 09046290
Hyphenated Format 0904-6290

Supplemental Identifiers

RxCUI
617310 617312
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
  • 50 BLISTER PACK in 1 CARTON (0904-6290-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-6290-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

Ingredients (1)

atorvastatin calcium propylene glycol solvate (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "71aa6f50-677d-4d87-a990-4f7c91a67c8b", "openfda": {"unii": ["YRZ789OWMI"], "rxcui": ["617310", "617312"], "spl_set_id": ["634ec8e3-6d83-4cb2-90a3-fc9c973b06bf"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6290-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6290-06", "marketing_start_date": "20120529"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6290-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6290-61", "marketing_start_date": "20120529"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "0904-6290_71aa6f50-677d-4d87-a990-4f7c91a67c8b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0904-6290", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Major Pharmaceuticals", "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"}