pravastatin sodium

Generic: pravastatin sodium

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler mylan institutional inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 20 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-458
Product ID 51079-458_311a7c70-966e-2400-e063-6394a90aae6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076056
Marketing Start 2006-05-22
Marketing End 2026-08-31

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 51079458
Hyphenated Format 51079-458

Supplemental Identifiers

RxCUI
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 ANDA076056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-458-20) / 1 TABLET in 1 BLISTER PACK (51079-458-01)
source: ndc

Packages (1)

51079-458-20 100 BLISTER PACK in 1 CARTON (51079-458-20) / 1 TABLET in 1 BLISTER PACK (51079-458-01)

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": "311a7c70-966e-2400-e063-6394a90aae6a", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904467", "904475"], "spl_set_id": ["1b00f510-c86d-46f6-b427-311a8fd14955"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-458-20)  / 1 TABLET in 1 BLISTER PACK (51079-458-01)", "package_ndc": "51079-458-20", "marketing_end_date": "20260831", "marketing_start_date": "20060522"}], "brand_name": "Pravastatin Sodium", "product_id": "51079-458_311a7c70-966e-2400-e063-6394a90aae6a", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "51079-458", "generic_name": "Pravastatin Sodium", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin Sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA076056", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20060522"}