pravastatin sodium

Generic: pravastatin sodium

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

Drug Facts

Product Profile

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

pravastatin sodium 40 mg/1

Manufacturer
CIPLA USA INC.

Identifiers & Regulatory

Product NDC 69097-791
Product ID 69097-791_0233b0be-de76-4a43-b318-70d14d8955aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077987
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

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 69097791
Hyphenated Format 69097-791

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UPC
0369097792053 0369097791056 0369097788124 0369097789053 0369097789121 0369097788056 0369097791124 0369097792121
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
  • 90 TABLET in 1 BOTTLE (69097-791-05)
  • 500 TABLET in 1 BOTTLE (69097-791-12)
source: ndc

Packages (2)

69097-791-05 90 TABLET in 1 BOTTLE (69097-791-05) 69097-791-12 500 TABLET in 1 BOTTLE (69097-791-12)

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": "0233b0be-de76-4a43-b318-70d14d8955aa", "openfda": {"upc": ["0369097792053", "0369097791056", "0369097788124", "0369097789053", "0369097789121", "0369097788056", "0369097791124", "0369097792121"], "unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["678dfe58-3200-4c3d-9718-365aa47d070f"], "manufacturer_name": ["CIPLA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (69097-791-05)", "package_ndc": "69097-791-05", "marketing_start_date": "20240601"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69097-791-12)", "package_ndc": "69097-791-12", "marketing_start_date": "20240601"}], "brand_name": "PRAVASTATIN SODIUM", "product_id": "69097-791_0233b0be-de76-4a43-b318-70d14d8955aa", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "69097-791", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "CIPLA USA INC.", "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": "20240601", "listing_expiration_date": "20261231"}