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 8 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Preferred Pharmaceuticals Inc.	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	2025-02-12	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Pravastatin Sodium	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	2d40e473-f79a-e50e-e063-6294a90a4d9e	2025-02-03	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	Chartwell RX, LLC	f87016fb-4c01-4279-8cf7-59819971ca15	2025-01-30	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	7b900a28-f20e-49d5-98a9-5513fee0a901	2025-01-30	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 71335-1243-3 ndc (package): 71335-1243-1 ndc (package): 71335-1243-2 ndc (product): 71335-1243 rxcui: 904458 spl id: bfb6cf43-415c-42f1-8cc6-ac4f1eff0dca spl set id: 7b900a28-f20e-49d5-98a9-5513fee0a901 unii: 3M8608UQ61
Prunus Iron	PRUNUS IRON	Uriel Pharmacy Inc.	091be588-b62e-4919-8e9e-3edb9792d319	2025-01-22	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	DIRECT RX	97178675-3691-2d93-e053-2995a90aa5c1	2025-01-17	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 72189-060-90 ndc (package): 72189-059-90 ndc (package): 72189-060-30 ndc (package): 72189-119-90 ndc (package): 72189-061-30 ndc (package): 72189-061-90 ndc (product): 72189-119 ndc (product): 72189-059 ndc (product): 72189-060 ndc (product): 72189-061 rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 spl id: 2be8f6ba-328a-86ab-e063-6394a90acb89 spl set id: 97178675-3691-2d93-e053-2995a90aa5c1 unii: 3M8608UQ61
Ferrum Silicicum Urtica	FERRUM SILICICUM URTICA	Uriel Pharmacy Inc.	09829ac4-c074-7315-e063-6394a90adf59	2025-01-07	Warnings	Exact identifier unii: 1K09F3G675
Pravastatin Sodium	PRAVASTATIN SODIUM	Quality Care Products, LLC	465dc828-966e-4bb4-b935-ef26583dd4e6	2024-12-19	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	Lake Erie Medical DBA Quality Care Products LLC	e7194af1-6304-4e3e-88ab-0825706a3962	2024-12-11	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 35356-919-30 ndc (package): 35356-921-60 ndc (package): 35356-919-90 ndc (package): 35356-125-90 ndc (package): 35356-921-90 ndc (package): 35356-919-60 ndc (package): 35356-921-30 ndc (package): 35356-125-60 ndc (package): 35356-125-30 ndc (product): 35356-919 ndc (product): 35356-125 ndc (product): 35356-921 rxcui: 904458 rxcui: 904467 rxcui: 904475 spl id: 77f23591-e677-43b5-8ed8-47059fc8ed3f spl set id: e7194af1-6304-4e3e-88ab-0825706a3962 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae	2024-12-06	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	55f8cf43-bf8b-4729-9e5a-32fcc9696e02	2024-10-30	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	7b4ef7a8-47e5-428f-91de-7307dcbb9167	2024-10-23	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904481 unii: 3M8608UQ61
Caladryl	FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE	Bausch Health US, LLC	67d4fd42-9fed-4238-9f5a-c9403abbcf20	2024-10-17	Warnings	Exact identifier unii: 1K09F3G675
Calamine	CALAMINE AND ZINC OXIDE	Strategic Sourcing Services, LLC	22173332-9d09-768c-e063-6394a90a94e1	2024-09-14	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	6bb60d07-0787-4d5f-8a8c-1224d5b02b2b	2024-08-30	Warnings, Adverse reactions	Exact identifier rxcui: 904458 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	06d85243-f9df-4984-b3d3-fcd8a7c554e9	2024-08-20	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	01beb7e2-ba01-4f2f-8554-4a8ec0941c9f	2024-08-14	Warnings, Adverse reactions	Exact identifier rxcui: 904481 unii: 3M8608UQ61
dba364fe-8aa7-4e97-80a7-18a2dbab2b51			1772dfd3-4ff1-40f6-a392-6681aa5f60b7	2024-07-30	Warnings, Adverse reactions	Exact identifier spl set id: 1772dfd3-4ff1-40f6-a392-6681aa5f60b7
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	54228087-7ab0-5561-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals,Inc.	548bdd9f-dcc6-28c7-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904475 unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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