pravastatin sodium

Generic: pravastatin sodium

Labeler: lake erie medical dba quality care products llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler lake erie medical dba quality care products llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 20 mg/1

Manufacturer
Lake Erie Medical DBA Quality Care Products LLC

Identifiers & Regulatory

Product NDC 35356-919
Product ID 35356-919_77f23591-e677-43b5-8ed8-47059fc8ed3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076341
Marketing Start 2011-07-18
Marketing End 2028-04-30

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 35356919
Hyphenated Format 35356-919

Supplemental Identifiers

RxCUI
904458 904467 904475
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 ANDA076341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (35356-919-30)
  • 90 TABLET in 1 BOTTLE (35356-919-90)
source: ndc

Packages (2)

35356-919-30 30 TABLET in 1 BOTTLE (35356-919-30) 35356-919-90 90 TABLET in 1 BOTTLE (35356-919-90)

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": "77f23591-e677-43b5-8ed8-47059fc8ed3f", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475"], "spl_set_id": ["e7194af1-6304-4e3e-88ab-0825706a3962"], "manufacturer_name": ["Lake Erie Medical DBA Quality Care Products LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (35356-919-30)", "package_ndc": "35356-919-30", "marketing_end_date": "20280430", "marketing_start_date": "20110718"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (35356-919-90)", "package_ndc": "35356-919-90", "marketing_end_date": "20280430", "marketing_start_date": "20110718"}], "brand_name": "Pravastatin Sodium", "product_id": "35356-919_77f23591-e677-43b5-8ed8-47059fc8ed3f", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "35356-919", "generic_name": "pravastatin sodium", "labeler_name": "Lake Erie Medical DBA Quality Care Products LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin Sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA076341", "marketing_category": "ANDA", "marketing_end_date": "20280430", "marketing_start_date": "20110718"}