FDA.reportPublic FDA data

NDC 63629-8833-01 - 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
63629-8833
Requested NDC
63629-8833-01
Package NDCs from labels
63629-8833-1, 63629-8833-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-11-14
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 Prepack2025-11-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8833-1PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8833PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20250216_2ba7af14-9c87-4eb0-84c9-7e895cd75fae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8833-1EA - Each63629-8833322f2c4f-8013-4950-97b4-8e06988893e812021-12-08

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 2 of 9 · 179 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.8dbdc80d-9d8c-4e22-9108-d87a77e07a6b2026-07-07Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMSafecor Health LLC0ae196a4-be3d-4cd8-9ff2-68aeb91b86782026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
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
rxcui: 904467
unii: 3M8608UQ61
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepackf074240e-ef6b-45f2-8c4d-cb5c0dbc81f12026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC9289f9ed-b6e3-4e81-bdb8-6aedbd5288a92026-06-11Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack3686a2df-51c4-4f1c-9d1e-d692079151442026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack14390bfa-3bcb-43e1-936c-1977cb37427d2026-06-04Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack8d1bf7a5-bf11-47e3-afca-dcc13f2d30682026-06-04Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackd0641def-425e-4357-a6b6-24ce004245492026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackdcf46d0c-87da-4009-b238-eb5cf287c3ed2026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.2ded7e5e-c377-4495-a045-f1c57b90c5db2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.46fdf929-c961-4dd9-8865-8eb4adaa259a2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackdaacdad5-f75d-4f9f-b623-8071f3bef91e2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMAmici Pharma, Inc.e6551230-fe4c-4a6e-9c19-ae9945b76db02026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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