pravastatin sodium

Generic: pravastatin sodium

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 80 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-637
Product ID 71610-637_5d082e37-f27a-4be2-bf4c-8e1c5bb976af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076341
Listing Expiration 2026-12-31
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 71610637
Hyphenated Format 71610-637

Supplemental Identifiers

RxCUI
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
  • 30 TABLET in 1 BOTTLE (71610-637-30)
  • 45 TABLET in 1 BOTTLE (71610-637-45)
source: ndc

Packages (2)

71610-637-30 30 TABLET in 1 BOTTLE (71610-637-30) 71610-637-45 45 TABLET in 1 BOTTLE (71610-637-45)

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": "5d082e37-f27a-4be2-bf4c-8e1c5bb976af", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904481"], "spl_set_id": ["ce61f570-2564-429b-8775-157e8e32d378"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-637-30)", "package_ndc": "71610-637-30", "marketing_start_date": "20220224"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-637-45)", "package_ndc": "71610-637-45", "marketing_start_date": "20220224"}], "brand_name": "PRAVASTATIN SODIUM", "product_id": "71610-637_5d082e37-f27a-4be2-bf4c-8e1c5bb976af", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-637", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20110718", "listing_expiration_date": "20261231"}