pravastatin sodium

Generic: pravastatin sodium

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler northstar rxllc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 20 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-559
Product ID 16714-559_fa078b35-ee9d-4b9f-bb8d-e77949c09f88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077987
Listing Expiration 2026-12-31
Marketing Start 2022-08-12

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 16714559
Hyphenated Format 16714-559

Supplemental Identifiers

RxCUI
904458 904467 904475 904481
UPC
0316714570013 0316714559018 0316714560014
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 ANDA077987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (16714-559-01)
  • 500 TABLET in 1 BOTTLE (16714-559-02)
source: ndc

Packages (2)

16714-559-01 90 TABLET in 1 BOTTLE (16714-559-01) 16714-559-02 500 TABLET in 1 BOTTLE (16714-559-02)

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": "fa078b35-ee9d-4b9f-bb8d-e77949c09f88", "openfda": {"upc": ["0316714570013", "0316714559018", "0316714560014"], "unii": ["3M8608UQ61"], "rxcui": ["904458", "904467", "904475", "904481"], "spl_set_id": ["ce15ad07-3286-478f-9f30-1db6a45ed402"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (16714-559-01)", "package_ndc": "16714-559-01", "marketing_start_date": "20220812"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16714-559-02)", "package_ndc": "16714-559-02", "marketing_start_date": "20220812"}], "brand_name": "Pravastatin Sodium", "product_id": "16714-559_fa078b35-ee9d-4b9f-bb8d-e77949c09f88", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "16714-559", "generic_name": "Pravastatin Sodium", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin Sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA077987", "marketing_category": "ANDA", "marketing_start_date": "20220812", "listing_expiration_date": "20261231"}