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 9 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	NuCare Pharmaceuticals,Inc.	8e9d5896-0b7c-dbd4-e053-2a95a90ae2f6	2024-06-18	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 68071-5001-3 ndc (product): 68071-5001 rxcui: 904458 spl id: 1b30c5cb-3c68-6b34-e063-6394a90a89a3 spl set id: 8e9d5896-0b7c-dbd4-e053-2a95a90ae2f6 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals,Inc.	8ed7879d-988c-1a27-e053-2995a90a0361	2024-06-18	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 ndc (package): 68071-5007-3 ndc (product): 68071-5007 rxcui: 904458 spl id: 1b30df7b-a982-9706-e063-6394a90a5ea1 spl set id: 8ed7879d-988c-1a27-e053-2995a90a0361 unii: 3M8608UQ61
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	73633a65-93b9-46dd-8f9f-d4b5c0089040	2024-06-05	Warnings, Adverse reactions	Exact identifier rxcui: 904458 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	24471777-5cd6-4c46-a5f2-a349fadc830e	2024-04-04	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	Direct_Rx	7f814fd9-7b35-67da-e053-2a91aa0a39dc	2024-01-10	Warnings, Adverse reactions	Exact identifier rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	Teva Pharmaceuticals USA, Inc.	99e0e848-f8f3-4b42-b880-8fbc42633948	2024-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Lupin Pharmaceuticals, Inc.	1123d56c-16f0-4f81-b56f-67b1f343ae1e	2023-12-19	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904481 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	4f9ada33-5592-4780-926d-1af49a8e064e	2023-12-15	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	a75de063-c751-4647-bb9e-d4050c1e31fc	2023-12-14	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	70920620-37d6-4fe0-9d86-1fdffc2e6a99	2023-10-25	Warnings, Adverse reactions	Exact identifier rxcui: 904481 unii: 3M8608UQ61
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier unii: H3R47K3TBD
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier unii: H3R47K3TBD
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier unii: H3R47K3TBD
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	4d2b4607-0a46-4b58-9247-dc448ce258ec	2023-08-01	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	Proficient Rx LP	466e2d1a-a6d6-40f8-a9f6-3e7494a34ca6	2023-08-01	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
Ferrum Oxydatum	FERRUM OXYDATUM	Hahnemann Laboratories, INC.	f8b52d3f-3fe2-a850-e053-6394a90a5d9f	2023-04-06		Exact identifier unii: 1K09F3G675
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	4948e795-8c33-40e2-ae85-208962daee72	2023-02-06	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d	2023-02-06	Warnings, Adverse reactions	Exact identifier rxcui: 904481 unii: 3M8608UQ61
d813587e-5ec4-662f-e053-2a95a90ac27e			90b80470-99a5-96da-e053-2995a90a0eda	2023-01-01	Warnings, Adverse reactions	Exact identifier spl id: d813587e-5ec4-662f-e053-2a95a90ac27e spl set id: 90b80470-99a5-96da-e053-2995a90a0eda

Reported adverse events (FAERS/openFDA)#

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