pravastatin sodium
Generic: pravastatin sodium
Labeler: lupin pharmaceuticals, inc.Drug Facts
Product Profile
Brand Name
pravastatin sodium
Generic Name
pravastatin sodium
Labeler
lupin pharmaceuticals, inc.
Dosage Form
TABLET
Routes
Active Ingredients
pravastatin sodium 80 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
68180-488
Product ID
68180-488_a173dd76-57cb-4066-a51f-26adfb79e861
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA077917
Listing Expiration
2026-12-31
Marketing Start
2008-07-24
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
68180488
Hyphenated Format
68180-488
Supplemental Identifiers
RxCUI
UPC
UNII
Packaging Origin
Original Packager
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
ANDA077917 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 80 mg/1
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Pravastatin sodium tablets USP are supplied as: 10 mg tablets: Yellow coloured, capsule shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'N01' on the other side. They are supplied in bottles of 90 (NDC 68180-485-09), bottles of 500 (NDC 68180-485-02) and bottles of 1000 (NDC 68180-485-03). 20 mg tablets: Yellow coloured, capsule shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'N02' on the other side. They are supplied in bottles of 90 (NDC 68180-486-09), bottles of 500 (NDC 68180-486-02) and bottles of 1000 (NDC 68180-486-03). 40 mg tablets: Yellow coloured, capsule shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'N03' on the other side. They are supplied in bottles of 90 (NDC 68180-487-09), bottles of 500 (NDC 68180-487-02) and bottles of 1000 (NDC 68180-487-03). 80 mg tablets: Yellow coloured, oval shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'N04' on the other side. They are supplied in bottles of 90 (NDC 68180-488-09), bottles of 500 (NDC 68180-488-02) and bottles of 1000 (NDC 68180-488-03). Store at 25 ο C (77 ο F); excursions permitted to 15 ο C to 30 ο C (59 ο to 86 ο F). Keep tightly closed (protect from moisture).Protect from light.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRAVASTATIN SODIUM TABLETS USP 10 mg Rx Only NDC 68180-485-09 90 Tablets PRAVASTATIN SODIUM TABLETS USP 20 mg Rx Only NDC 68180-486-09 90 Tablets PRAVASTATIN SODIUM TABLETS USP 40 mg Rx Only NDC 68180-487-09 90 Tablets PRAVASTATIN SODIUM TABLETS USP 80 mg Rx Only NDC 68180-488-09 90 Tablets image-03 image-04 image-05 image-06
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "a173dd76-57cb-4066-a51f-26adfb79e861", "openfda": {"upc": ["0368180487098"], "unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["1123d56c-16f0-4f81-b56f-67b1f343ae1e"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "PRAVASTATIN SODIUM", "product_id": "68180-488_a173dd76-57cb-4066-a51f-26adfb79e861", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68180-488", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRAVASTATIN SODIUM", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "80 mg/1"}], "application_number": "ANDA077917", "marketing_category": "ANDA", "marketing_start_date": "20080724", "listing_expiration_date": "20261231"}