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 trihydrate 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-153
Product ID 72789-153_40a76a5c-e09f-b8b7-e063-6394a90a9aff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211933
Listing Expiration 2026-12-31
Marketing Start 2019-02-08

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 72789153
Hyphenated Format 72789-153

Supplemental Identifiers

RxCUI
617312
UPC
0372789153308
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 ANDA211933 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-153-30)
source: ndc

Packages (1)

72789-153-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-153-30)

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": "40a76a5c-e09f-b8b7-e063-6394a90a9aff", "openfda": {"upc": ["0372789153308"], "unii": ["48A5M73Z4Q"], "rxcui": ["617312"], "spl_set_id": ["4509aa67-06d4-41d1-80b6-c9bd8ad0bf07"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-153-30)", "package_ndc": "72789-153-30", "marketing_start_date": "20200201"}], "brand_name": "Atorvastatin calcium", "product_id": "72789-153_40a76a5c-e09f-b8b7-e063-6394a90a9aff", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72789-153", "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 TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA211933", "marketing_category": "ANDA", "marketing_start_date": "20190208", "listing_expiration_date": "20261231"}