pravastatin sodium

Generic: pravastatin sodium

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 10 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8539
Product ID 0615-8539_78590b33-7097-47fe-8a37-034aea661387
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077987
Marketing Start 2024-06-01
Marketing End 2026-10-31

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 06158539
Hyphenated Format 0615-8539

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UNII
3M8608UQ61

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 ANDA077987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (0615-8539-39)
source: ndc

Packages (1)

0615-8539-39 30 TABLET in 1 BLISTER PACK (0615-8539-39)

Ingredients (1)

pravastatin sodium (10 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": "78590b33-7097-47fe-8a37-034aea661387", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8539-39)", "package_ndc": "0615-8539-39", "marketing_end_date": "20261031", "marketing_start_date": "20241119"}], "brand_name": "PRAVASTATIN SODIUM", "product_id": "0615-8539_78590b33-7097-47fe-8a37-034aea661387", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0615-8539", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRAVASTATIN SODIUM", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA077987", "marketing_category": "ANDA", "marketing_end_date": "20261031", "marketing_start_date": "20240601"}