pravastatin sodium

Generic: pravastatin sodium

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 80 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-668
Product ID 50268-668_47fb4c90-456b-508c-e063-6394a90a5da5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076341
Listing Expiration 2027-12-31
Marketing Start 2021-02-01

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 50268668
Hyphenated Format 50268-668

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UNII
3M8608UQ61

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
  • 80 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX (50268-668-12) / 1 TABLET in 1 BLISTER PACK (50268-668-11)
source: ndc

Packages (1)

50268-668-12 20 BLISTER PACK in 1 BOX (50268-668-12) / 1 TABLET in 1 BLISTER PACK (50268-668-11)

Ingredients (1)

pravastatin sodium (80 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": "47fb4c90-456b-508c-e063-6394a90a5da5", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["ba4ac602-46fa-8386-e053-2995a90a9764"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX (50268-668-12)  / 1 TABLET in 1 BLISTER PACK (50268-668-11)", "package_ndc": "50268-668-12", "marketing_start_date": "20210201"}], "brand_name": "PRAVASTATIN SODIUM", "product_id": "50268-668_47fb4c90-456b-508c-e063-6394a90a5da5", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "50268-668", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRAVASTATIN SODIUM", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "80 mg/1"}], "application_number": "ANDA076341", "marketing_category": "ANDA", "marketing_start_date": "20210201", "listing_expiration_date": "20271231"}