rosuvastatin

Generic: rosuvastatin

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

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-882
Product ID 31722-882_49d450b0-95af-a362-e063-6294a90a3e99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207616
Listing Expiration 2027-12-31
Marketing Start 2016-10-29

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 31722882
Hyphenated Format 31722-882

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0331722885300 0331722883900 0331722884907
UNII
83MVU38M7Q

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 rosuvastatin (source: ndc)
Generic Name rosuvastatin (source: ndc)
Application Number ANDA207616 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (31722-882-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-882-05)
  • 100 TABLET, FILM COATED in 1 CARTON (31722-882-31)
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-882-90)
source: ndc

Packages (4)

31722-882-01 1000 TABLET, FILM COATED in 1 BOTTLE (31722-882-01) 31722-882-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-882-05) 31722-882-31 100 TABLET, FILM COATED in 1 CARTON (31722-882-31) 31722-882-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-882-90)

Ingredients (1)

rosuvastatin calcium (5 mg/1)

Linked Drug Pages (1)

Rosuvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49d450b0-95af-a362-e063-6294a90a3e99", "openfda": {"upc": ["0331722885300", "0331722883900", "0331722884907"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["7778df5a-82c1-4a86-8867-a3325da025ec"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-882-01)", "package_ndc": "31722-882-01", "marketing_start_date": "20240209"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-882-05)", "package_ndc": "31722-882-05", "marketing_start_date": "20240209"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 CARTON (31722-882-31)", "package_ndc": "31722-882-31", "marketing_start_date": "20161029"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-882-90)", "package_ndc": "31722-882-90", "marketing_start_date": "20161029"}], "brand_name": "Rosuvastatin", "product_id": "31722-882_49d450b0-95af-a362-e063-6294a90a3e99", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "31722-882", "generic_name": "Rosuvastatin", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA207616", "marketing_category": "ANDA", "marketing_start_date": "20161029", "listing_expiration_date": "20271231"}