NDC 60505-0168-01 - 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: 60505-0168
Requested NDC: 60505-0168-01
Package NDCs from labels: 60505-0168-9, 60505-0168-1, 60505-0168-5, 60505-0168-7, 60505-0168-4, 60505-0168-01
Manufacturer: REMEDYREPACK INC.
Effective date: 2026-09-22
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.	2026-09-22	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Major Pharmaceuticals	Major Pharmaceuticals	2026-09-17	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Apotex Corp. \| Apotex Inc.	Apotex Corp. \| Apotex Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Northwind Health Company, LLC	Northwind Health Company, LLC	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-03-25	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 - AvPAK	AvPAK	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - A-S Medication Solutions	A-S Medication Solutions	2026-01-06	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Coupler LLC \| Apotex Inc.	Coupler LLC \| Apotex Inc.	2025-12-08	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - DIRECT RX	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL
Pravastatin Sodium - Lake Erie Medical DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL
PRAVASTATIN SODIUM - Preferred Pharmaceuticals Inc..	Preferred Pharmaceuticals Inc..	2023-09-05	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-0168-1	PRAVASTATIN SODIUM	100 in 1 BOTTLE	TABLET	100	18
60505-0168-4	PRAVASTATIN SODIUM	40000 in 1 BOTTLE	TABLET	40000	18
60505-0168-5	PRAVASTATIN SODIUM	500 in 1 BOTTLE	TABLET	500	18
60505-0168-7	PRAVASTATIN SODIUM	1000 in 1 BOTTLE	TABLET	1000	18
60505-0168-9	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
60505-0168	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
60505-0168-5	EA - Each	60505-0168	667abd48-648e-41bf-99c2-e657f5b4dcbb	1	2012-07-24
60505-0168-9	EA - Each	60505-0168	75a2ec7b-b94a-46ad-833a-56b0693c9caa	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
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
pravastatin sodium	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
pravastatin	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
pravastatin sodium	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
pravastatin	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1

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 5 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	df75b04e-3e85-9705-e053-2995a90af83f	2026-01-01	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904481 unii: 3M8608UQ61
Dermagesic	PRAMOXINE HCL, ZINC OXIDE, CALAMINE	Llorens Pharmaceutical International Division	bbff6b53-29da-45c1-8ccd-3e9df7f250e0	2025-12-31	Warnings	Exact identifier unii: 1K09F3G675
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	47207487-0c6d-8da3-e063-6294a90a8aee	2025-12-29	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
BABY ANTI MONKEY BUTT DIAPER RASH	ZINC OXIDE, CALAMINE	Clarion Brands, LLC	e4424d74-f89c-5943-42e8-bf3a38e68619	2025-12-23	Warnings	Exact identifier unii: 1K09F3G675
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	471b4dac-057d-740c-e063-6294a90af9e9	2025-12-19	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	fd76794d-de33-4886-875c-fa05b2639f84	2025-12-10	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Coupler LLC	4573c42b-6d4a-e001-e063-6294a90acea1	2025-12-08	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 67046-1621-3 ndc (product): 67046-1621 rxcui: 904458 spl id: 4573c662-e92e-dffe-e063-6294a90a71da spl set id: 4573c42b-6d4a-e001-e063-6294a90acea1 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	f92e12bc-40c3-4afa-9190-2f4de11ec6b3	2025-12-08	Warnings, Adverse reactions	Exact identifier rxcui: 904458 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	12943de2-c7e9-4651-89f3-fc6cb5276676	2025-11-17	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904475 unii: 3M8608UQ61
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Kroger Co.	6b3e7aac-395f-48cf-9c5e-f7e163724aef	2025-11-17	Warnings	Exact identifier unii: 1K09F3G675
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	HY-VEE, INC	415ecfe9-3145-f23e-e063-6394a90adfd8	2025-11-17	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	97123f09-b5ad-45c2-8bb7-f50566b56b08	2025-11-17	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904481 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	2ba7af14-9c87-4eb0-84c9-7e895cd75fae	2025-11-14	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 63629-8833-1 ndc (product): 63629-8833 rxcui: 904458 spl id: 167a2550-ca7b-4990-8c0f-5922af045614 spl set id: 2ba7af14-9c87-4eb0-84c9-7e895cd75fae unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Accord Healthcare Inc.	6c011348-a236-47d3-bbef-3e0b956dd080	2025-11-14	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	4ed7a4d1-1183-4d95-8311-6d3e58feafa8	2025-11-10	Warnings, Adverse reactions	Exact identifier rxcui: 904458 unii: 3M8608UQ61
Au Kah Chuen Fugical	CALAMINE AND DIPHENHYDRAMINE HYDROCHLORID	Zhejiang Dingtai Pharmaceutical Co., Ltd	5b4add17-6c3d-4093-826a-2edb41c1d1db	2025-11-10	Warnings	Exact identifier unii: 1K09F3G675
FARGELIN HEMORRHOIDAL	CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE	MADISON ONE ACME INC	6844ad63-512d-496a-9458-011894185b0d	2025-11-10	Warnings	Exact identifier unii: 1K09F3G675
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f	2025-11-10	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
Calamine Plus	CALAMINE PLUS PRAMOXINE HCL	Chain Drug Marketing Association Inc	1a3f8819-58cf-8923-e063-6394a90a37af	2025-11-06	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	abcfc343-7ac9-4fce-b368-fd05cf14b0e2	2025-11-04	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904481 unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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