atorvastatin calcium

Generic: atorvastatin calcium

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

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3595
Product ID 68071-3595_16c5ab95-c8f6-0308-e063-6394a90a84c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216436
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

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 680713595
Hyphenated Format 68071-3595

Supplemental Identifiers

RxCUI
617311
UPC
0368071359596
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 ANDA216436 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68071-3595-9)
source: ndc

Packages (1)

68071-3595-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-3595-9)

Ingredients (1)

atorvastatin calcium trihydrate (40 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": "16c5ab95-c8f6-0308-e063-6394a90a84c6", "openfda": {"upc": ["0368071359596"], "unii": ["48A5M73Z4Q"], "rxcui": ["617311"], "spl_set_id": ["16c59ba4-1cb7-e23f-e063-6294a90a1683"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68071-3595-9)", "package_ndc": "68071-3595-9", "marketing_start_date": "20240423"}], "brand_name": "Atorvastatin Calcium", "product_id": "68071-3595_16c5ab95-c8f6-0308-e063-6394a90a84c6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68071-3595", "generic_name": "atorvastatin calcium", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA216436", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}