rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: biocon pharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler biocon pharma inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Biocon Pharma Inc

Identifiers & Regulatory

Product NDC 70377-006
Product ID 70377-006_843cb1f2-e29f-1cea-4a98-e34470827fba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207752
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 70377006
Hyphenated Format 70377-006

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0370377008122 0370377009112 0370377007125 0370377006128
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 ANDA207752 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-11)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-12)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-13)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-15)
source: ndc

Packages (4)

70377-006-11 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-11) 70377-006-12 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-12) 70377-006-13 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-13) 70377-006-15 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-15)

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": "843cb1f2-e29f-1cea-4a98-e34470827fba", "openfda": {"upc": ["0370377008122", "0370377009112", "0370377007125", "0370377006128"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["033d8c8f-bbe9-96b5-fd53-cb0ef929857a"], "manufacturer_name": ["Biocon Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-11)", "package_ndc": "70377-006-11", "marketing_start_date": "20161031"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-12)", "package_ndc": "70377-006-12", "marketing_start_date": "20161031"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-13)", "package_ndc": "70377-006-13", "marketing_start_date": "20161031"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-15)", "package_ndc": "70377-006-15", "marketing_start_date": "20190927"}], "brand_name": "Rosuvastatin calcium", "product_id": "70377-006_843cb1f2-e29f-1cea-4a98-e34470827fba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70377-006", "generic_name": "Rosuvastatin calcium", "labeler_name": "Biocon Pharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA207752", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}