atorvastatin calcium

Generic: atorvastatin calcium

Labeler: dr. reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler dr. reddy's laboratories inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-101
Product ID 43598-101_d4e74ed4-46a8-d079-8e3e-299f10d739cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214659
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

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 43598101
Hyphenated Format 43598-101

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
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 ANDA214659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (43598-101-05)
  • 10 BLISTER PACK in 1 CARTON (43598-101-78) / 10 TABLET in 1 BLISTER PACK (43598-101-10)
  • 90 TABLET in 1 BOTTLE (43598-101-90)
source: ndc

Packages (3)

43598-101-05 500 TABLET in 1 BOTTLE (43598-101-05) 43598-101-78 10 BLISTER PACK in 1 CARTON (43598-101-78) / 10 TABLET in 1 BLISTER PACK (43598-101-10) 43598-101-90 90 TABLET in 1 BOTTLE (43598-101-90)

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": "d4e74ed4-46a8-d079-8e3e-299f10d739cd", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["aaf960d1-8bf9-64c6-1e70-8aa33b0ce549"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (43598-101-05)", "package_ndc": "43598-101-05", "marketing_start_date": "20240401"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (43598-101-78)  / 10 TABLET in 1 BLISTER PACK (43598-101-10)", "package_ndc": "43598-101-78", "marketing_start_date": "20240401"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43598-101-90)", "package_ndc": "43598-101-90", "marketing_start_date": "20240401"}], "brand_name": "Atorvastatin Calcium", "product_id": "43598-101_d4e74ed4-46a8-d079-8e3e-299f10d739cd", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "43598-101", "generic_name": "Atorvastatin Calcium", "labeler_name": "Dr. Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA214659", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}