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 3 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	Amici Pharma, Inc.	e6551230-fe4c-4a6e-9c19-ae9945b76db0	2026-05-19	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	CVS Pharmacy	db6f518d-3a0e-43f8-8d19-7382d9b7ff1c	2026-05-11	Warnings	Exact identifier unii: 1K09F3G675
Calamine	FERRIC OXIDE RED	Retail Business Services, LLC	7291e175-a9b6-4c47-93ce-227ce11e4599	2026-04-30	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Pravastatin sodium	PRAVASTATIN SODIUM	Golden State Medical Supply, Inc.	25b7276e-a69f-af63-e063-6394a90aecf2	2026-04-21	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	4fad5d73-aa79-58f2-e063-6294a90af4aa	2026-04-16	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 82868-104-30 ndc (product): 82868-104 rxcui: 904458 spl id: 4fad51aa-7705-438c-e063-6294a90ae565 spl set id: 4fad5d73-aa79-58f2-e063-6294a90af4aa unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	93b0e546-9e0f-40d1-9b1e-082bf16400a4	2026-04-13	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	d69e8af8-dbd4-43d9-8e9a-4aed3923a17c	2026-04-13	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904475 unii: 3M8608UQ61
Calamine	CALAMINE 8%, ZINC OXIDE 8%	Farmacias De Similares TX LLC	4ecd0add-11c9-cf3b-e063-6394a90adff6	2026-04-06	Warnings	Exact identifier unii: 1K09F3G675
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	b7f8c679-a602-4268-81b6-962a136a4e43	2026-04-02	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	8df47d82-5b09-414d-99f1-7ac4c77f7c01	2026-04-02	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f4b330ce-dfb0-4e4e-9f37-482458820c66	2026-03-25	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 72162-1706-9 ndc (package): 72162-1706-2 ndc (package): 72162-1706-3 ndc (product): 72162-1706 rxcui: 904458 spl id: 18567e6b-ccfd-4ab7-9287-7629ea8b5ffc spl set id: f4b330ce-dfb0-4e4e-9f37-482458820c66 unii: 3M8608UQ61
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	4d3a0a92-b0de-a1ea-e063-6294a90a8508	2026-03-17	Warnings	Exact identifier unii: 1K09F3G675
Calamine	CALAMINE, PRAMOXINE HCL	Amazon.com Services LLC	aceb0b10-8c90-4a06-8c47-cd1a2b4676a3	2026-03-03	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
1fc88a70-8c13-4db5-97e5-e0f356ce65aa			1d5bce9c-a788-4c52-a69e-c53174b8d061	2026-03-02	Warnings, Adverse reactions	Exact identifier spl id: 1fc88a70-8c13-4db5-97e5-e0f356ce65aa spl set id: 1d5bce9c-a788-4c52-a69e-c53174b8d061
Calamine	FERRIC OXIDE RED	Old East Main Co.	c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d	2026-03-02	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine	FERRIC OXIDE RED	Chain Drug Marketing Association	86ff4875-9007-4b7b-8f46-16cbd475d4bb	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine	CALAMINE, PRAMOXINE HCL	Chain Drug Marketing Association	6c848b98-f01c-40f2-a9aa-2af76cb370c8	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Levico Prunus	LEVICO PRUNUS	Uriel Pharmacy Inc.	63db9374-8ee2-48cf-8799-454c95869808	2026-02-27	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	64ccb4b5-b77e-4b23-8c74-4685287edb4b	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 0615-8619-39 ndc (package): 0615-8619-05 ndc (package): 0615-8620-39 ndc (package): 0615-8620-05 ndc (package): 0615-8621-39 ndc (package): 0615-8618-39 ndc (product): 0615-8621 ndc (product): 0615-8618 ndc (product): 0615-8619 ndc (product): 0615-8620 rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 spl id: c9527ee1-8502-4ce1-b02a-e73e80c893f8 spl set id: 64ccb4b5-b77e-4b23-8c74-4685287edb4b unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Biocon Pharma Inc.	9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb	2026-02-26	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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