pravastatin sodium

Generic: pravastatin sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 40 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-634
Product ID 65862-634_ec34b688-92eb-42c2-b417-c3aa7f0a0ece
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203367
Listing Expiration 2026-12-31
Marketing Start 2017-02-02

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 65862634
Hyphenated Format 65862-634

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UPC
0365862632906
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 ANDA203367 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (65862-634-05)
  • 90 TABLET in 1 BOTTLE (65862-634-90)
  • 1000 TABLET in 1 BOTTLE (65862-634-99)
source: ndc

Packages (3)

65862-634-05 500 TABLET in 1 BOTTLE (65862-634-05) 65862-634-90 90 TABLET in 1 BOTTLE (65862-634-90) 65862-634-99 1000 TABLET in 1 BOTTLE (65862-634-99)

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": "ec34b688-92eb-42c2-b417-c3aa7f0a0ece", "openfda": {"upc": ["0365862632906"], "unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["b06ed801-ddee-4f56-924a-59fcb451eae6"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-634-05)", "package_ndc": "65862-634-05", "marketing_start_date": "20170202"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65862-634-90)", "package_ndc": "65862-634-90", "marketing_start_date": "20170202"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-634-99)", "package_ndc": "65862-634-99", "marketing_start_date": "20170202"}], "brand_name": "Pravastatin sodium", "product_id": "65862-634_ec34b688-92eb-42c2-b417-c3aa7f0a0ece", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "65862-634", "generic_name": "Pravastatin sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA203367", "marketing_category": "ANDA", "marketing_start_date": "20170202", "listing_expiration_date": "20261231"}