pravastatin sodium

Generic: pravastatin sodium

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler accord healthcare inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 20 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-009
Product ID 16729-009_438f9112-0851-75e1-e063-6294a90a675c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207068
Listing Expiration 2026-12-31
Marketing Start 2017-02-16

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 16729009
Hyphenated Format 16729-009

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
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 ANDA207068 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (16729-009-15)
  • 500 TABLET in 1 BOTTLE (16729-009-16)
  • 1000 TABLET in 1 BOTTLE (16729-009-17)
source: ndc

Packages (3)

16729-009-15 90 TABLET in 1 BOTTLE (16729-009-15) 16729-009-16 500 TABLET in 1 BOTTLE (16729-009-16) 16729-009-17 1000 TABLET in 1 BOTTLE (16729-009-17)

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": "438f9112-0851-75e1-e063-6294a90a675c", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["6c011348-a236-47d3-bbef-3e0b956dd080"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (16729-009-15)", "package_ndc": "16729-009-15", "marketing_start_date": "20170216"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16729-009-16)", "package_ndc": "16729-009-16", "marketing_start_date": "20170216"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (16729-009-17)", "package_ndc": "16729-009-17", "marketing_start_date": "20170216"}], "brand_name": "PRAVASTATIN SODIUM", "product_id": "16729-009_438f9112-0851-75e1-e063-6294a90a675c", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "16729-009", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRAVASTATIN SODIUM", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA207068", "marketing_category": "ANDA", "marketing_start_date": "20170216", "listing_expiration_date": "20261231"}