pravastatin sodium

Generic: pravastatin sodium

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 10 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0168
Product ID 60505-0168_4ee96b96-8019-3bb3-6737-f6f88c6289d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076341
Listing Expiration 2027-12-31
Marketing Start 2011-07-18

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 605050168
Hyphenated Format 60505-0168

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UPC
0360505132393
UNII
3M8608UQ61

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 pravastatin sodium (source: ndc)
Generic Name pravastatin sodium (source: ndc)
Application Number ANDA076341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (60505-0168-1)
  • 40000 TABLET in 1 BOTTLE (60505-0168-4)
  • 500 TABLET in 1 BOTTLE (60505-0168-5)
  • 1000 TABLET in 1 BOTTLE (60505-0168-7)
  • 90 TABLET in 1 BOTTLE (60505-0168-9)
source: ndc

Packages (5)

60505-0168-1 100 TABLET in 1 BOTTLE (60505-0168-1) 60505-0168-4 40000 TABLET in 1 BOTTLE (60505-0168-4) 60505-0168-5 500 TABLET in 1 BOTTLE (60505-0168-5) 60505-0168-7 1000 TABLET in 1 BOTTLE (60505-0168-7) 60505-0168-9 90 TABLET in 1 BOTTLE (60505-0168-9)

Ingredients (1)

pravastatin sodium (10 mg/1)

Linked Drug Pages (1)

PRAVASTATIN SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ee96b96-8019-3bb3-6737-f6f88c6289d9", "openfda": {"upc": ["0360505132393"], "unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["dcf45e4f-b46e-6fbb-b67a-2ff619ab1780"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (60505-0168-1)", "package_ndc": "60505-0168-1", "marketing_start_date": "20110718"}, {"sample": false, "description": "40000 TABLET in 1 BOTTLE (60505-0168-4)", "package_ndc": "60505-0168-4", "marketing_start_date": "20110718"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (60505-0168-5)", "package_ndc": "60505-0168-5", "marketing_start_date": "20110718"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (60505-0168-7)", "package_ndc": "60505-0168-7", "marketing_start_date": "20110718"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (60505-0168-9)", "package_ndc": "60505-0168-9", "marketing_start_date": "20110718"}], "brand_name": "PRAVASTATIN SODIUM", "product_id": "60505-0168_4ee96b96-8019-3bb3-6737-f6f88c6289d9", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "60505-0168", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRAVASTATIN SODIUM", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA076341", "marketing_category": "ANDA", "marketing_start_date": "20110718", "listing_expiration_date": "20271231"}