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 5 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC47207487-0c6d-8da3-e063-6294a90a8aee2025-12-29Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC471b4dac-057d-740c-e063-6294a90af9e92025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutionsfd76794d-de33-4886-875c-fa05b2639f842025-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCoupler LLC4573c42b-6d4a-e001-e063-6294a90acea12025-12-08Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.f92e12bc-40c3-4afa-9190-2f4de11ec6b32025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack12943de2-c7e9-4651-89f3-fc6cb52766762025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack97123f09-b5ad-45c2-8bb7-f50566b56b082025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack2ba7af14-9c87-4eb0-84c9-7e895cd75fae2025-11-14Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.6c011348-a236-47d3-bbef-3e0b956dd0802025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack4ed7a4d1-1183-4d95-8311-6d3e58feafa82025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f2025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackabcfc343-7ac9-4fce-b368-fd05cf14b0e22025-11-04Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.e6a3d99c-c9cc-49d9-b0f9-503770307b702025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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