pravastatin sodium

Generic: pravastatin sodium

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4339
Product ID 70518-4339_4030e199-7260-81fc-e063-6394a90a315b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076056
Listing Expiration 2026-12-31
Marketing Start 2025-05-13

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 705184339
Hyphenated Format 70518-4339

Supplemental Identifiers

RxCUI
904475
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 ANDA076056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-4339-0)
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-4339-1)
source: ndc

Packages (2)

70518-4339-0 30 TABLET in 1 BLISTER PACK (70518-4339-0) 70518-4339-1 90 TABLET in 1 BOTTLE, PLASTIC (70518-4339-1)

Ingredients (1)

pravastatin sodium (40 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": "4030e199-7260-81fc-e063-6394a90a315b", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904475"], "spl_set_id": ["fa152ce7-6c07-4aaf-9374-932ce81d0cf9"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-4339-0)", "package_ndc": "70518-4339-0", "marketing_start_date": "20250513"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-4339-1)", "package_ndc": "70518-4339-1", "marketing_start_date": "20250825"}], "brand_name": "Pravastatin sodium", "product_id": "70518-4339_4030e199-7260-81fc-e063-6394a90a315b", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70518-4339", "generic_name": "Pravastatin sodium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA076056", "marketing_category": "ANDA", "marketing_start_date": "20250513", "listing_expiration_date": "20261231"}