atorvastatin calcium

Generic: atorvastatin calcium, film coated

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium, film coated
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-139
Product ID 16571-139_b94c6347-161c-44f2-8937-34c5098bf755
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209912
Listing Expiration 2026-12-31
Marketing Start 2023-10-20

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 16571139
Hyphenated Format 16571-139

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0316571136094 0316571138098 0316571137091
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, film coated (source: ndc)
Application Number ANDA209912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (16571-139-09)
  • 1000 TABLET in 1 BOTTLE (16571-139-10)
  • 500 TABLET in 1 BOTTLE (16571-139-50)
source: ndc

Packages (3)

16571-139-09 90 TABLET in 1 BOTTLE (16571-139-09) 16571-139-10 1000 TABLET in 1 BOTTLE (16571-139-10) 16571-139-50 500 TABLET in 1 BOTTLE (16571-139-50)

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": "b94c6347-161c-44f2-8937-34c5098bf755", "openfda": {"upc": ["0316571136094", "0316571138098", "0316571137091"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["73cefb0b-1747-4fe0-b252-377f4ed94c6f"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (16571-139-09)", "package_ndc": "16571-139-09", "marketing_start_date": "20231020"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (16571-139-10)", "package_ndc": "16571-139-10", "marketing_start_date": "20231020"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16571-139-50)", "package_ndc": "16571-139-50", "marketing_start_date": "20231020"}], "brand_name": "Atorvastatin Calcium", "product_id": "16571-139_b94c6347-161c-44f2-8937-34c5098bf755", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "16571-139", "generic_name": "atorvastatin calcium, film coated", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA209912", "marketing_category": "ANDA", "marketing_start_date": "20231020", "listing_expiration_date": "20261231"}