NDC 60505-1323-01 - 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: 60505-1323
Requested NDC: 60505-1323-01
Package NDCs from labels: 60505-1323-9, 60505-1323-1, 60505-1323-5, 60505-1323-7, 60505-1323-8, 60505-1323-01
Manufacturer: Preferred Pharmaceuticals Inc..
Effective date: 2026-08-17
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 - Preferred Pharmaceuticals Inc..	Preferred Pharmaceuticals Inc..	2026-08-17	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Apotex Corp. \| Apotex Inc.	Apotex Corp. \| Apotex Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - NCS HealthCare of KY, LLC dba Vangard Labs \| Apotex Inc.	NCS HealthCare of KY, LLC dba Vangard Labs \| Apotex Inc.	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - AvPAK	AvPAK	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Northwind Health Company, LLC	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - DIRECT RX	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - A-S Medication Solutions	A-S Medication Solutions	2024-10-23	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2022-03-03	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - REMEDYREPACK INC.	REMEDYREPACK INC.	2019-07-10	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-23	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-1323-1	PRAVASTATIN SODIUM	100 in 1 BOTTLE	TABLET	100	18
60505-1323-5	PRAVASTATIN SODIUM	500 in 1 BOTTLE	TABLET	500	18
60505-1323-7	PRAVASTATIN SODIUM	1000 in 1 BOTTLE	TABLET	1000	18
60505-1323-8	PRAVASTATIN SODIUM	5000 in 1 BOTTLE	TABLET	5000	18
60505-1323-9	PRAVASTATIN SODIUM	90 in 1 BOTTLE	TABLET	90	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-1323	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	16	Current NDC, Legacy NDC, 5 package rows	20241211_dcf45e4f-b46e-6fbb-b67a-2ff619ab1780.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-1323-5	EA - Each	60505-1323	a7fe643d-d6c9-4bd9-b52d-78458044b90d	1	2012-07-24
60505-1323-9	EA - Each	60505-1323	60cf2245-2f14-4bf4-b74e-861a31330858	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6

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 · 192 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
Calamine	CALAMINE, PRAMOXINE HCL	United Natural Foods, Inc. dba UNFI	0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea	2026-09-04	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
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
Calamine	FERRIC OXIDE RED	Your Military Exchanges	af95a66c-f063-4019-80c6-6f7dc4fee4d8	2026-08-28	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine Plus	CALAMINE, PRAMOXINE HYDROCHLORIDE	Kroger Company	44fdd5a4-3cac-15e5-e063-6294a90adb52	2026-08-26	Warnings	Exact identifier unii: 1K09F3G675
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 rxcui: 904467 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 ndc (package): 68788-7660-0 ndc (package): 68788-7660-9 ndc (package): 68788-7660-2 ndc (package): 68788-7660-6 ndc (package): 68788-7660-8 ndc (package): 68788-7660-3 ndc (product): 68788-7660 rxcui: 904481 spl id: 418c65fd-0357-4974-87ae-7246a23b87cb spl set id: ebd794ba-90c3-4d81-9c45-4aa9d9454359 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
Calamine	FERRIC OXIDE RED	The Kroger Co.	9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308	2026-08-06	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
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 (package): 60505-1323-7 ndc (package): 60505-1323-1 ndc (package): 60505-0168-5 ndc (package): 60505-0169-1 ndc (package): 60505-1323-5 ndc (package): 60505-0168-7 ndc (package): 60505-0170-7 ndc (package): 60505-0168-9 ndc (package): 60505-0169-7 ndc (package): 60505-0170-5 ndc (package): 60505-0168-1 ndc (package): 60505-0169-2 ndc (package): 60505-0170-9 ndc (package): 60505-1323-9 ndc (package): 60505-0169-5 ndc (package): 60505-0168-4 ndc (package): 60505-0170-8 ndc (package): 60505-1323-8 ndc (package): 60505-0170-1 ndc (package): 60505-0169-9 ndc (product): 60505-0170 ndc (product): 60505-0169 ndc (product): 60505-1323 ndc (product): 60505-0168 ndc11 (package): 60505132301 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
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	57110309-9a3d-025f-e063-6394a90a015a	2026-07-22	Warnings	Exact identifier unii: 1K09F3G675
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	571083ce-cd35-a638-e063-6394a90ae4c7	2026-07-20	Warnings	Exact identifier unii: 1K09F3G675
Calamine	FERRIC OXIDE RED	Better Living Brands, LLC	c7ef0ef3-6861-4b94-af4b-371fee8c1f3d	2026-07-16	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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