NDC 51079-782-01 - 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: 51079-782
Requested NDC: 51079-782-01
Package NDCs from labels: 51079-782-01, 51079-782-20
Manufacturer: Cardinal Health 107, LLC
Effective date: 2026-07-10
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 - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL
Pravastatin Sodium - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-03-24	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51079-782-01	Pravastatin Sodium	1 in 1 BLISTER PACK	TABLET	1		14
51079-782-20	Pravastatin Sodium	100 in 1 CARTON	TABLET	100		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51079-782	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	14	Legacy NDC, 2 package rows	20250326_1b00f510-c86d-46f6-b427-311a8fd14955.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-782-01	EA - Each	51079-782	cde33c60-30b6-40ea-8e47-88f5e2a3b9c8	1	2012-07-24
51079-782-20	EA - Each	51079-782	bf50d2f1-7ee3-4740-84c2-d44e32b4fbfb	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 [MYLAN INSTITUTIONAL INC.]	4
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3

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 8 · 145 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 application number: ANDA076056 rxcui: 904467 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	fa152ce7-6c07-4aaf-9374-932ce81d0cf9	2026-09-04	Warnings, Adverse reactions	Exact identifier application number: ANDA076056 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	5ecd9fd1-7662-412d-99c5-13c77188748c	2026-08-21	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	2026-08-21	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	6d42bd30-1f09-49f4-9ec8-31366df1b4b4	2026-08-17	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	46cdd32d-a022-4acf-ba2b-10e7877d56c6	2026-08-17	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc..	ebd794ba-90c3-4d81-9c45-4aa9d9454359	2026-08-17	Warnings, Adverse reactions	Exact identifier 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 rxcui: 904458 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Quallent	e9c188f7-cd6f-afac-b493-36552d86589e	2026-08-03	Warnings, Adverse reactions	Exact identifier 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 rxcui: 904458 rxcui: 904467 rxcui: 904475 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: 904467 rxcui: 904475 unii: 3M8608UQ61
7f1c20ba-37fd-4008-8fda-560511e99fd8			ca779f66-4b9d-41da-ad0e-e4f58db9fbac	2026-07-10	Warnings, Adverse reactions	Exact identifier spl id: 7f1c20ba-37fd-4008-8fda-560511e99fd8 spl set id: ca779f66-4b9d-41da-ad0e-e4f58db9fbac
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5f611aa-9974-422e-a353-5d834a33937c	2026-07-07	Warnings, Adverse reactions	Exact identifier 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 rxcui: 904475 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Safecor Health LLC	0ae196a4-be3d-4cd8-9ff2-68aeb91b8678	2026-07-01	Warnings, Adverse reactions	Exact identifier application number: ANDA076056 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 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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