NDC 70518-1938-00 - 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: 70518-1938
Requested NDC: 70518-1938-00
Package NDCs from labels: 70518-1938-0, 70518-1938-1, 70518-1938-00
Manufacturer: REMEDYREPACK INC.
Effective date: 2026-08-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PRAVASTATIN SODIUM - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-08-21	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-1938-0	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-03-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-0	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-1938-1	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-1938-0	PRAVASTATIN SODIUM	30 in 1 BLISTER PACK	TABLET	30		13
70518-1938-1	PRAVASTATIN SODIUM	90 in 1 BOTTLE, PLASTIC	TABLET	90		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1938	PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]	9	Current NDC, Legacy NDC, 2 package rows	20250303_e4dbaa72-7b3e-4aef-983b-90efb2b343cd.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 7 · 122 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	6cef5e92-26b7-435c-878f-72a05a624560	2026-09-10	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	fa152ce7-6c07-4aaf-9374-932ce81d0cf9	2026-09-04	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	CIPLA USA INC.	678dfe58-3200-4c3d-9718-365aa47d070f	2026-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	5ecd9fd1-7662-412d-99c5-13c77188748c	2026-08-21	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	2026-08-21	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 70518-1938-0 ndc (package): 70518-1938-1 ndc (product): 70518-1938 ndc11 (package): 70518193800 rxcui: 904467 spl id: 5992f12f-b7b1-692d-e063-6394a90ae8e7 spl set id: e4dbaa72-7b3e-4aef-983b-90efb2b343cd unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	6d42bd30-1f09-49f4-9ec8-31366df1b4b4	2026-08-17	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	46cdd32d-a022-4acf-ba2b-10e7877d56c6	2026-08-17	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc..	ebd794ba-90c3-4d81-9c45-4aa9d9454359	2026-08-17	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904481 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	095ac6fd-fdfb-4207-b15d-8e93bee378c3	2026-08-17	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	3e218ad6-5b47-4cca-81be-ebaea5795964	2026-08-13	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904458 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Quallent	e9c188f7-cd6f-afac-b493-36552d86589e	2026-08-03	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Apotex Corp.	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (product): 60505-0169 rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 spl id: 23a54cde-a404-07d5-9a4f-e7297930c0e5 spl set id: dcf45e4f-b46e-6fbb-b67a-2ff619ab1780 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Aurobindo Pharma Limited	b06ed801-ddee-4f56-924a-59fcb451eae6	2026-07-29	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5f611aa-9974-422e-a353-5d834a33937c	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	8dbdc80d-9d8c-4e22-9108-d87a77e07a6b	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904475 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Safecor Health LLC	0ae196a4-be3d-4cd8-9ff2-68aeb91b8678	2026-07-01	Warnings, Adverse reactions	Exact identifier rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	American Health Packaging	97f826f0-b5c5-410c-b1f0-523873981e8d	2026-06-17	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ca7a4143-0091-4cd5-9061-cb05cc84ea4e	2026-06-16	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1	2026-06-11	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9	2026-06-11	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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