rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler bryant ranch prepack
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-7158
Product ID 63629-7158_7bb53b84-80ef-49f2-9fdb-678f5301558c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201619
Listing Expiration 2026-12-31
Marketing Start 2016-10-31

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 636297158
Hyphenated Format 63629-7158

Supplemental Identifiers

RxCUI
859424
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 ANDA201619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (63629-7158-1)
  • 90 TABLET, COATED in 1 BOTTLE (63629-7158-2)
  • 28 TABLET, COATED in 1 BOTTLE (63629-7158-3)
  • 60 TABLET, COATED in 1 BOTTLE (63629-7158-4)
  • 100 TABLET, COATED in 1 BOTTLE (63629-7158-5)
source: ndc

Packages (5)

63629-7158-1 30 TABLET, COATED in 1 BOTTLE (63629-7158-1) 63629-7158-2 90 TABLET, COATED in 1 BOTTLE (63629-7158-2) 63629-7158-3 28 TABLET, COATED in 1 BOTTLE (63629-7158-3) 63629-7158-4 60 TABLET, COATED in 1 BOTTLE (63629-7158-4) 63629-7158-5 100 TABLET, COATED in 1 BOTTLE (63629-7158-5)

Ingredients (1)

rosuvastatin calcium (5 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": "7bb53b84-80ef-49f2-9fdb-678f5301558c", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859424"], "spl_set_id": ["1c97c9da-687b-47c1-9b9e-61f9a37bb9c4"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (63629-7158-1)", "package_ndc": "63629-7158-1", "marketing_start_date": "20180316"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (63629-7158-2)", "package_ndc": "63629-7158-2", "marketing_start_date": "20161209"}, {"sample": false, "description": "28 TABLET, COATED in 1 BOTTLE (63629-7158-3)", "package_ndc": "63629-7158-3", "marketing_start_date": "20241008"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (63629-7158-4)", "package_ndc": "63629-7158-4", "marketing_start_date": "20241008"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (63629-7158-5)", "package_ndc": "63629-7158-5", "marketing_start_date": "20241008"}], "brand_name": "Rosuvastatin Calcium", "product_id": "63629-7158_7bb53b84-80ef-49f2-9fdb-678f5301558c", "dosage_form": "TABLET, COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "63629-7158", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA201619", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}