FDA.reportPublic FDA data

NDC 60429-367-90 - PRAVASTATIN SODIUM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60429-367
Requested NDC
60429-367-90
Package NDCs from labels
60429-367-45, 60429-367-90
Manufacturer
Golden State Medical Supply
Effective date
2020-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAVASTATIN SODIUM - Golden State Medical SupplyGolden State Medical Supply2020-05-19HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-367-05EA - Each60429-367011b9274-dbc6-426a-b966-b33e6936c53712012-07-24
60429-367-45EA - Each60429-367aa7c1f20-cf41-4c5b-b383-458e40c1852712017-04-05
60429-367-90EA - Each60429-36786ed33f1-c41b-4a61-b8af-cd1a59ca2f0512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pravastatin sodiumACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2
pravastatinACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2
magnesium stearateINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions2f658680-939a-4212-8a5e-a44a896dd2212026-02-11Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions3b9fe7c9-791e-49a0-a005-ccf13036c3652026-02-11Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackc0b1b483-1a19-4966-89b1-118ec660f2032026-01-29Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAvPAKba4ac602-46fa-8386-e053-2995a90a97642026-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: 1K09F3G675
Third Chakra (Solar Plexus) 7303THIRD CHAKRA (SOLAR PLEXUS)Professional Complementary Health Formulaseea89c37-ab87-4cc7-8dfc-e7f42a580dd92026-01-08WarningsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf212026-01-06Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC40aa2d36-57ce-1f48-e063-6294a90affef2026-01-02Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMNorthwind Health Company, LLCdb0e9c21-dc25-629a-e053-2a95a90a5ac32026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Health Company, LLCdb5b8821-dca8-9322-e053-2a95a90abdc32026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Health Company, LLCdf75b04e-3e85-9705-e053-2995a90af83f2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.