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 43353-966
Product ID 43353-966_0d6fa0b8-bef8-42ff-8b4e-ea21b291a8e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077793
Listing Expiration 2026-12-31
Marketing Start 2014-06-17

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 43353966
Hyphenated Format 43353-966

Supplemental Identifiers

RxCUI
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 ANDA077793 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE (43353-966-45)
  • 90 TABLET in 1 BOTTLE (43353-966-60)
source: ndc

Packages (2)

43353-966-45 45 TABLET in 1 BOTTLE (43353-966-45) 43353-966-60 90 TABLET in 1 BOTTLE (43353-966-60)

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": "0d6fa0b8-bef8-42ff-8b4e-ea21b291a8e2", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904475", "904481"], "spl_set_id": ["576f2e65-2bf6-4f6b-8538-50221f2d88bb"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET in 1 BOTTLE (43353-966-45)", "package_ndc": "43353-966-45", "marketing_start_date": "20140930"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-966-60)", "package_ndc": "43353-966-60", "marketing_start_date": "20210120"}], "brand_name": "Pravastatin Sodium", "product_id": "43353-966_0d6fa0b8-bef8-42ff-8b4e-ea21b291a8e2", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "43353-966", "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": "ANDA077793", "marketing_category": "ANDA", "marketing_start_date": "20140617", "listing_expiration_date": "20261231"}