NDC 0591-0019-05 - 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: 0591-0019
Requested NDC: 0591-0019-05
Package NDCs from labels: 0591-0019-19, 0591-0019-05
Manufacturer: Watson Laboratories, Inc.
Effective date: 2008-10-06
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 Tablets	Watson Laboratories, Inc.	2008-10-06	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-0019	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3	Unmatched	20081121_AD3DA3C3-66B2-09FE-2C85-AAF4367E3732.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
pravastatin sodium	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
pravastatin	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
croscramellose sodium	INACTIVE INGREDIENT		PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
Green Lake Blend (mixture of D&C Yellow No. 10-Aluminum Lake and FD&C Blue No. 1-Aluminum Lake)	INACTIVE INGREDIENT		PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
lactose	INACTIVE INGREDIENT	J2B2A4N98G	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
magnesium oxide	INACTIVE INGREDIENT	3A3U0GI71G	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
microcrystalline cellulose	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
povidone	INACTIVE INGREDIENT	FZ989GH94E	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
Red Ferric Oxide	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	3
Yellow Ferric Oxide	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]	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 6 · 119 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
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	fa152ce7-6c07-4aaf-9374-932ce81d0cf9	2026-09-04	Warnings, Adverse reactions	Exact identifier rxcui: 904475
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	5ecd9fd1-7662-412d-99c5-13c77188748c	2026-08-21	Warnings, Adverse reactions	Exact identifier rxcui: 904475
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	2026-08-21	Warnings, Adverse reactions	Exact identifier rxcui: 904467
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	6d42bd30-1f09-49f4-9ec8-31366df1b4b4	2026-08-17	Warnings, Adverse reactions	Exact identifier rxcui: 904467
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	46cdd32d-a022-4acf-ba2b-10e7877d56c6	2026-08-17	Warnings, Adverse reactions	Exact identifier rxcui: 904475
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc..	ebd794ba-90c3-4d81-9c45-4aa9d9454359	2026-08-17	Warnings, Adverse reactions	Exact identifier rxcui: 904481
Pravastatin Sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	095ac6fd-fdfb-4207-b15d-8e93bee378c3	2026-08-17	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904467
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	3e218ad6-5b47-4cca-81be-ebaea5795964	2026-08-13	Warnings, Adverse reactions	Exact identifier rxcui: 904458
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Quallent	e9c188f7-cd6f-afac-b493-36552d86589e	2026-08-03	Warnings, Adverse reactions	Exact identifier rxcui: 904481 rxcui: 904467 rxcui: 904475
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Apotex Corp.	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	2026-07-31	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475
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
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5f611aa-9974-422e-a353-5d834a33937c	2026-07-07	Warnings, Adverse reactions	Exact identifier rxcui: 904467
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	8dbdc80d-9d8c-4e22-9108-d87a77e07a6b	2026-07-07	Warnings, Adverse reactions	Exact identifier rxcui: 904475
Pravastatin sodium	PRAVASTATIN SODIUM	Safecor Health LLC	0ae196a4-be3d-4cd8-9ff2-68aeb91b8678	2026-07-01	Warnings, Adverse reactions	Exact identifier rxcui: 904467 rxcui: 904475
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
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ca7a4143-0091-4cd5-9061-cb05cc84ea4e	2026-06-16	Warnings, Adverse reactions	Exact identifier rxcui: 904467
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1	2026-06-11	Warnings, Adverse reactions	Exact identifier rxcui: 904475
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
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	3686a2df-51c4-4f1c-9d1e-d69207915144	2026-06-11	Warnings, Adverse reactions	Exact identifier rxcui: 904475

Reported adverse events (FAERS/openFDA)#

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