pravastatin sodium

Generic: pravastatin sodium

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pravastatin sodium 20 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-848
Product ID 62135-848_2cf16f1b-c67f-455e-e063-6394a90adc0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077917
Listing Expiration 2026-12-31
Marketing Start 2024-09-26

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 62135848
Hyphenated Format 62135-848

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UPC
0362135850906 0362135848903 0362135847906 0362135849900
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 ANDA077917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-848-90)
source: ndc

Packages (1)

62135-848-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-848-90)

Ingredients (1)

pravastatin sodium (20 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": "2cf16f1b-c67f-455e-e063-6394a90adc0a", "openfda": {"upc": ["0362135850906", "0362135848903", "0362135847906", "0362135849900"], "unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["f87016fb-4c01-4279-8cf7-59819971ca15"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-848-90)", "package_ndc": "62135-848-90", "marketing_start_date": "20240926"}], "brand_name": "Pravastatin Sodium", "product_id": "62135-848_2cf16f1b-c67f-455e-e063-6394a90adc0a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "62135-848", "generic_name": "Pravastatin Sodium", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin Sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA077917", "marketing_category": "ANDA", "marketing_start_date": "20240926", "listing_expiration_date": "20261231"}