atorvastatin calcium

Generic: atorvastatin calcium

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-080
Product ID 70377-080_72b8b3f5-4658-80af-655c-87ce7966a5e6
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 70377080
Hyphenated Format 70377-080

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0370377080111
UNII
48A5M73Z4Q

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 ANDA216436 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (70377-080-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70377-080-12)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70377-080-13)
source: ndc

Packages (3)

70377-080-11 90 TABLET, FILM COATED in 1 BOTTLE (70377-080-11) 70377-080-12 500 TABLET, FILM COATED in 1 BOTTLE (70377-080-12) 70377-080-13 1000 TABLET, FILM COATED in 1 BOTTLE (70377-080-13)

Ingredients (1)

atorvastatin calcium trihydrate (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": "72b8b3f5-4658-80af-655c-87ce7966a5e6", "openfda": {"upc": ["0370377080111"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["5b839619-1805-c227-91bf-182f5b966ba4"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70377-080-11)", "package_ndc": "70377-080-11", "marketing_start_date": "20230301"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70377-080-12)", "package_ndc": "70377-080-12", "marketing_start_date": "20230301"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70377-080-13)", "package_ndc": "70377-080-13", "marketing_start_date": "20230301"}], "brand_name": "Atorvastatin Calcium", "product_id": "70377-080_72b8b3f5-4658-80af-655c-87ce7966a5e6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70377-080", "generic_name": "atorvastatin calcium", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA216436", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}