pravastatin sodium

Generic: pravastatin sodium

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 40 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-197
Product ID 68462-197_a6e006b3-4256-4cbb-8ad1-b71f363430cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077987
Listing Expiration 2026-12-31
Marketing Start 2007-05-11

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 68462197
Hyphenated Format 68462-197

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UPC
0368462195901 0368462198902
UNII
3M8608UQ61

Packaging Origin

Original Packager
true

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 ANDA077987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (68462-197-05)
  • 90 TABLET in 1 BOTTLE (68462-197-90)
source: ndc

Packages (2)

68462-197-05 500 TABLET in 1 BOTTLE (68462-197-05) 68462-197-90 90 TABLET in 1 BOTTLE (68462-197-90)

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": "a6e006b3-4256-4cbb-8ad1-b71f363430cd", "openfda": {"upc": ["0368462195901", "0368462198902"], "unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (68462-197-05)", "package_ndc": "68462-197-05", "marketing_start_date": "20070511"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68462-197-90)", "package_ndc": "68462-197-90", "marketing_start_date": "20070511"}], "brand_name": "Pravastatin Sodium", "product_id": "68462-197_a6e006b3-4256-4cbb-8ad1-b71f363430cd", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68462-197", "generic_name": "Pravastatin Sodium", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin Sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA077987", "marketing_category": "ANDA", "marketing_start_date": "20070511", "listing_expiration_date": "20261231"}