FDA.reportPublic FDA data

NDC 63629-8910-01 - 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
63629-8910
Requested NDC
63629-8910-01
Package NDCs from labels
63629-8910-1, 63629-8910-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAVASTATIN SODIUM - Bryant Ranch PrepackBryant Ranch Prepack2025-04-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8910-1PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8910PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20250425_e358f314-9cbe-46a4-9564-6bedc7ef9d59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8910-1EA - Each63629-8910721484f3-49a3-4701-aa1c-f7c2adaf0d4912022-01-06

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 14 · 265 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin SodiumPRAVASTATIN SODIUMREMEDYREPACK INC.0c4b59f1-92a8-44f8-8b4c-691f357774602026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.e4dbaa72-7b3e-4aef-983b-90efb2b343cd2026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMCardinal Health 107, LLCca779f66-4b9d-41da-ad0e-e4f58db9fbac2026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.c5f611aa-9974-422e-a353-5d834a33937c2026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.8dbdc80d-9d8c-4e22-9108-d87a77e07a6b2026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Magnesium OxideMAGNESIUM OXIDEWestminster Pharmaceuticals, LLC52eeac0e-94bb-48c3-81dc-578e96406c012026-07-06WarningsExact identifier
unii: 3A3U0GI71G
Pravastatin sodiumPRAVASTATIN SODIUMSafecor Health LLC0ae196a4-be3d-4cd8-9ff2-68aeb91b86782026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.5ecd9fd1-7662-412d-99c5-13c77188748c2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.76e5fdf8-bd03-4cd5-9361-e61678cb3de92026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC3e218ad6-5b47-4cca-81be-ebaea57959642026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
VitramynFOLIC ACIDPureTek Corporationc8af7616-5178-6df0-e053-2a95a90a334d2026-06-18Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAmerican Health Packaging97f826f0-b5c5-410c-b1f0-523873981e8d2026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackca7a4143-0091-4cd5-9061-cb05cc84ea4e2026-06-16Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904467
unii: 3M8608UQ61
Prenate MiniASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRYAvion Pharmaceuticals, LLC8ab766c2-d554-4141-92b2-fbe038e80c9f2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Prenate EssentialASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENTAvion Pharmaceuticals, LLCe5acfb2a-0959-4542-9b4c-790be194d5812026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G