FDA.reportPublic FDA data

NDC 70518-0549-00 - 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
70518-0549
Requested NDC
70518-0549-00
Package NDCs from labels
70518-0549-0, 70518-0549-1, 70518-0549-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAVASTATIN SODIUM - REMEDYREPACK INC.REMEDYREPACK INC.2026-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0549-0PRAVASTATIN SODIUM30 in 1 BLISTER PACKTABLET3018
70518-0549-1PRAVASTATIN SODIUM90 in 1 BOTTLE, PLASTICTABLET9018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0549PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 2 package rows20250427_76e5fdf8-bd03-4cd5-9361-e61678cb3de9.zip

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 1 of 10 · 193 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
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.e4dbaa72-7b3e-4aef-983b-90efb2b343cd2026-07-16Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
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
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.5ecd9fd1-7662-412d-99c5-13c77188748c2026-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.76e5fdf8-bd03-4cd5-9361-e61678cb3de92026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA076341
ndc (package): 70518-0549-0
ndc (package): 70518-0549-1
ndc (product): 70518-0549
ndc11 (package): 70518054900
rxcui: 904458
spl id: 552d941a-e6d3-7c0b-e063-6294a90afcc5
spl set id: 76e5fdf8-bd03-4cd5-9361-e61678cb3de9
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC3e218ad6-5b47-4cca-81be-ebaea57959642026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
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