rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3623
Product ID 68071-3623_1aca7a77-ea9e-3417-e063-6394a90a20bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207626
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

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 680713623
Hyphenated Format 68071-3623

Supplemental Identifiers

RxCUI
859747
UPC
0368071362398
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 ANDA207626 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (68071-3623-9)
source: ndc

Packages (1)

68071-3623-9 90 TABLET in 1 BOTTLE (68071-3623-9)

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": "1aca7a77-ea9e-3417-e063-6394a90a20bd", "openfda": {"upc": ["0368071362398"], "unii": ["83MVU38M7Q"], "rxcui": ["859747"], "spl_set_id": ["1aca7a86-940b-c6e1-e063-6294a90a5944"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3623-9)", "package_ndc": "68071-3623-9", "marketing_start_date": "20240613"}], "brand_name": "Rosuvastatin Calcium", "product_id": "68071-3623_1aca7a77-ea9e-3417-e063-6394a90a20bd", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68071-3623", "generic_name": "Rosuvastatin Calcium", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "ANDA207626", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}