pravastatin sodium

Generic: pravastatin sodium

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pravastatin sodium 10 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1621
Product ID 67046-1621_4573c662-e92e-dffe-e063-6294a90a71da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076341
Listing Expiration 2026-12-31
Marketing Start 2025-12-08

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 670461621
Hyphenated Format 67046-1621

Supplemental Identifiers

RxCUI
904458
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
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1621-3)
source: ndc

Packages (1)

67046-1621-3 30 TABLET in 1 BLISTER PACK (67046-1621-3)

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": "4573c662-e92e-dffe-e063-6294a90a71da", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904458"], "spl_set_id": ["4573c42b-6d4a-e001-e063-6294a90acea1"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1621-3)", "package_ndc": "67046-1621-3", "marketing_start_date": "20251208"}], "brand_name": "PRAVASTATIN SODIUM", "product_id": "67046-1621_4573c662-e92e-dffe-e063-6294a90a71da", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "67046-1621", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "Coupler LLC", "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": "20251208", "listing_expiration_date": "20261231"}