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 4 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	Family Dollar Stores, Inc	1a03331e-3676-451c-be22-9a547e8ae6e2	2026-02-24	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine	FERRIC OXIDE RED	Perrigo Direct, Inc	256bd1d4-fd50-408f-9aee-84f218bb4971	2026-02-19	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine	CALAMINE, PRAMOXIND HCL	Perrigo Direct, Inc	54a20ec9-ab86-4410-af94-e04393e9d4b3	2026-02-19	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine	CALAMINE, PRAMOXINE HCL	Meijer, Inc.	6b369ef2-fd54-4931-a9eb-0fb42834c2ef	2026-02-19	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine	FERRIC OXIDE RED	Target Corporation	d4ee05c8-ae62-45df-8783-1ed57fa030ec	2026-02-18	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine	FERRIC OXIDE RED	Topco Associates LLC	2b32e720-ac71-4d60-bc06-e28a00f8a450	2026-02-13	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine	CALAMINE, PRAMOXINE HCL	Topco Associates LLC	15d1ae3f-509c-4e6b-8f0c-cf9265680358	2026-02-13	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	2f658680-939a-4212-8a5e-a44a896dd221	2026-02-11	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	3b9fe7c9-791e-49a0-a005-ccf13036c365	2026-02-11	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Calamine	FERRIC OXIDE RED	Major Pharmaceuticals	c25be68d-834a-4959-8d47-01ec789406ba	2026-02-04	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Aquavit 1	AQUAVIT 1	Uriel Pharmacy Inc.	2354fcfc-05a2-444a-ace4-b3df61413157	2026-02-02	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	c0b1b483-1a19-4966-89b1-118ec660f203	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904481 unii: 3M8608UQ61
Calamine	CALAMINE	AMERISOURCE BERGEN	90d9d908-57ea-4062-ade0-8a4888939c91	2026-01-29	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ba4ac602-46fa-8386-e053-2995a90a9764	2026-01-09	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 50268-667-15 ndc (package): 50268-666-11 ndc (package): 50268-666-15 ndc (package): 50268-665-15 ndc (package): 50268-667-11 ndc (package): 50268-668-12 ndc (package): 50268-668-11 ndc (package): 50268-665-11 ndc (product): 50268-666 ndc (product): 50268-668 ndc (product): 50268-667 ndc (product): 50268-665 rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 spl id: 47fb4c90-456b-508c-e063-6394a90a5da5 spl set id: ba4ac602-46fa-8386-e053-2995a90a9764 unii: 3M8608UQ61
First Chakra (Root) 7301	FIRST CHAKRA (ROOT)	Professional Complementary Health Formulas	61eb1bbe-6675-4369-b852-18975e6b08c7	2026-01-08	Warnings	Exact identifier unii: 1K09F3G675
Third Chakra (Solar Plexus) 7303	THIRD CHAKRA (SOLAR PLEXUS)	Professional Complementary Health Formulas	eea89c37-ab87-4cc7-8dfc-e7f42a580dd9	2026-01-08	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf21	2026-01-06	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 50090-3853-0 ndc (package): 50090-3853-1 ndc (product): 50090-3853 rxcui: 904458 spl id: 10559b70-d5be-41e8-a456-cbaa4753b604 spl set id: 3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf21 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	40aa2d36-57ce-1f48-e063-6294a90affef	2026-01-02	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	db0e9c21-dc25-629a-e053-2a95a90a5ac3	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	db5b8821-dca8-9322-e053-2a95a90abdc3	2026-01-01	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.