pravastatin sodium

Generic: pravastatin sodium

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler biocon pharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 40 mg/1

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-047
Product ID 70377-047_dc0074c0-e58a-3655-2a66-084168c39615
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209869
Listing Expiration 2027-12-31
Marketing Start 2021-02-01

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 70377047
Hyphenated Format 70377-047

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UPC
0370377048128
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 ANDA209869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70377-047-11)
  • 90 TABLET in 1 BOTTLE (70377-047-12)
  • 1000 TABLET in 1 BOTTLE (70377-047-14)
source: ndc

Packages (3)

70377-047-11 30 TABLET in 1 BOTTLE (70377-047-11) 70377-047-12 90 TABLET in 1 BOTTLE (70377-047-12) 70377-047-14 1000 TABLET in 1 BOTTLE (70377-047-14)

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": "dc0074c0-e58a-3655-2a66-084168c39615", "openfda": {"upc": ["0370377048128"], "unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70377-047-11)", "package_ndc": "70377-047-11", "marketing_start_date": "20210201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70377-047-12)", "package_ndc": "70377-047-12", "marketing_start_date": "20210201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (70377-047-14)", "package_ndc": "70377-047-14", "marketing_start_date": "20210201"}], "brand_name": "Pravastatin sodium", "product_id": "70377-047_dc0074c0-e58a-3655-2a66-084168c39615", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70377-047", "generic_name": "Pravastatin sodium", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA209869", "marketing_category": "ANDA", "marketing_start_date": "20210201", "listing_expiration_date": "20271231"}