rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-245
Product ID 60687-245_401aadf4-8665-4427-e063-6394a90a7820
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079170
Listing Expiration 2026-12-31
Marketing Start 2016-09-26

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 60687245
Hyphenated Format 60687-245

Supplemental Identifiers

RxCUI
859424 859747 859751
UNII
83MVU38M7Q

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 rosuvastatin calcium (source: ndc)
Generic Name rosuvastatin calcium (source: ndc)
Application Number ANDA079170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-245-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-245-11)
  • 50 BLISTER PACK in 1 CARTON (60687-245-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-245-11)
source: ndc

Packages (2)

60687-245-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-245-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-245-11) 60687-245-65 50 BLISTER PACK in 1 CARTON (60687-245-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-245-11)

Ingredients (1)

rosuvastatin calcium (10 mg/1)

Linked Drug Pages (1)

Rosuvastatin Calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "401aadf4-8665-4427-e063-6394a90a7820", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859424", "859747", "859751"], "spl_set_id": ["b7491a1a-570e-40ea-b65b-f956c9e284a6"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-245-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-245-11)", "package_ndc": "60687-245-01", "marketing_start_date": "20160926"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (60687-245-65)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-245-11)", "package_ndc": "60687-245-65", "marketing_start_date": "20230724"}], "brand_name": "Rosuvastatin Calcium", "product_id": "60687-245_401aadf4-8665-4427-e063-6394a90a7820", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "60687-245", "generic_name": "Rosuvastatin Calcium", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "ANDA079170", "marketing_category": "ANDA", "marketing_start_date": "20160926", "listing_expiration_date": "20261231"}