rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-439
Product ID 67877-439_e6a44b24-b851-40c2-92ef-ee7e9fe0d2db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206465
Listing Expiration 2026-12-31
Marketing Start 2017-03-21

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 67877439
Hyphenated Format 67877-439

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0367877441054 0367877440903
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 calcium (source: ndc)
Generic Name rosuvastatin calcium (source: ndc)
Application Number ANDA206465 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-439-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-439-30)
  • 10 TABLET, FILM COATED in 1 CARTON (67877-439-38)
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-439-90)
source: ndc

Packages (4)

67877-439-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-439-05) 67877-439-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-439-30) 67877-439-38 10 TABLET, FILM COATED in 1 CARTON (67877-439-38) 67877-439-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-439-90)

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": "e6a44b24-b851-40c2-92ef-ee7e9fe0d2db", "openfda": {"upc": ["0367877441054", "0367877440903"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["4ccbaa83-d57a-421e-88a8-1cee42d4207b"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-439-05)", "package_ndc": "67877-439-05", "marketing_start_date": "20170321"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-439-30)", "package_ndc": "67877-439-30", "marketing_start_date": "20170321"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 CARTON (67877-439-38)", "package_ndc": "67877-439-38", "marketing_start_date": "20170321"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-439-90)", "package_ndc": "67877-439-90", "marketing_start_date": "20170321"}], "brand_name": "Rosuvastatin Calcium", "product_id": "67877-439_e6a44b24-b851-40c2-92ef-ee7e9fe0d2db", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "67877-439", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA206465", "marketing_category": "ANDA", "marketing_start_date": "20170321", "listing_expiration_date": "20261231"}