pravastatin sodium

Generic: pravastatin sodium

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

Drug Facts

Product Profile

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

pravastatin sodium 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8425
Product ID 68788-8425_db446969-c9c0-49d9-ab68-050045fdbdc8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077987
Listing Expiration 2026-12-31
Marketing Start 2023-04-17

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 687888425
Hyphenated Format 68788-8425

Supplemental Identifiers

RxCUI
904458 904467
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 ANDA077987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68788-8425-3)
  • 60 TABLET in 1 BOTTLE (68788-8425-6)
  • 90 TABLET in 1 BOTTLE (68788-8425-9)
source: ndc

Packages (3)

68788-8425-3 30 TABLET in 1 BOTTLE (68788-8425-3) 68788-8425-6 60 TABLET in 1 BOTTLE (68788-8425-6) 68788-8425-9 90 TABLET in 1 BOTTLE (68788-8425-9)

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": "db446969-c9c0-49d9-ab68-050045fdbdc8", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904458", "904467"], "spl_set_id": ["095ac6fd-fdfb-4207-b15d-8e93bee378c3"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8425-3)", "package_ndc": "68788-8425-3", "marketing_start_date": "20230417"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8425-6)", "package_ndc": "68788-8425-6", "marketing_start_date": "20230417"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8425-9)", "package_ndc": "68788-8425-9", "marketing_start_date": "20230417"}], "brand_name": "Pravastatin Sodium", "product_id": "68788-8425_db446969-c9c0-49d9-ab68-050045fdbdc8", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8425", "generic_name": "Pravastatin Sodium", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin Sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA077987", "marketing_category": "ANDA", "marketing_start_date": "20230417", "listing_expiration_date": "20261231"}