atorvastatin calcium

Generic: atorvastatin calcium

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium propylene glycol solvate 80 mg/1

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-176
Product ID 16714-176_22845272-c73e-8982-c2f6-aa09f6c06d3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090548
Listing Expiration 2026-12-31
Marketing Start 2021-08-01

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 16714176
Hyphenated Format 16714-176

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UNII
YRZ789OWMI

Packaging Origin

Original Packager
true

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
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (16714-176-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16714-176-02)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16714-176-03)
source: ndc

Packages (3)

16714-176-01 90 TABLET, FILM COATED in 1 BOTTLE (16714-176-01) 16714-176-02 500 TABLET, FILM COATED in 1 BOTTLE (16714-176-02) 16714-176-03 1000 TABLET, FILM COATED in 1 BOTTLE (16714-176-03)

Ingredients (1)

atorvastatin calcium propylene glycol solvate (80 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": "22845272-c73e-8982-c2f6-aa09f6c06d3b", "openfda": {"unii": ["YRZ789OWMI"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["52d8508b-aa98-cd89-5991-e2b5f982b6c6"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16714-176-01)", "package_ndc": "16714-176-01", "marketing_start_date": "20210801"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16714-176-02)", "package_ndc": "16714-176-02", "marketing_start_date": "20210801"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16714-176-03)", "package_ndc": "16714-176-03", "marketing_start_date": "20210801"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "16714-176_22845272-c73e-8982-c2f6-aa09f6c06d3b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "16714-176", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE", "strength": "80 mg/1"}], "application_number": "ANDA090548", "marketing_category": "ANDA", "marketing_start_date": "20210801", "listing_expiration_date": "20261231"}