NDC 50090-3853-01 - 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: 50090-3853
Requested NDC: 50090-3853-01
Package NDCs from labels: 50090-3853-0, 50090-3853-1, 50090-3853-01
Manufacturer: A-S Medication Solutions
Effective date: 2026-01-06
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 - A-S Medication Solutions	A-S Medication Solutions	2026-01-06	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-3853-0	2023-02-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-3853-1	2023-02-07	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-3853-0	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-3853-1	2023-01-30	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3853-0	PRAVASTATIN SODIUM	90 in 1 BOTTLE	TABLET	90		11
50090-3853-1	PRAVASTATIN SODIUM	30 in 1 BOTTLE	TABLET	30		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3853	PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]	9	Current NDC, Legacy NDC, 2 package rows	20230511_3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf21.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3853-0	EA - Each	50090-3853	01f682fc-d2db-4b8d-9474-7c5ddf3c5ac0	1	2021-10-08
50090-3853-1	EA - Each	50090-3853	169b6ad4-8c7c-44ef-b834-aea17328c562	1	2021-10-08

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 2 of 9 · 179 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	8dbdc80d-9d8c-4e22-9108-d87a77e07a6b	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904475 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Safecor Health LLC	0ae196a4-be3d-4cd8-9ff2-68aeb91b8678	2026-07-01	Warnings, Adverse reactions	Exact identifier rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Target Corporation	36602b7a-99c0-f6a4-e063-6294a90a8758	2026-06-29	Warnings	Exact identifier unii: 1K09F3G675
CalaSoothe	CALAMINE, MENTHOL, AND ZINC OXIDE	Dynarex Corporation	54f12005-acfe-4821-e063-6394a90ac304	2026-06-24	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	American Health Packaging	97f826f0-b5c5-410c-b1f0-523873981e8d	2026-06-17	Warnings, Adverse reactions	Exact identifier rxcui: 904458 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ca7a4143-0091-4cd5-9061-cb05cc84ea4e	2026-06-16	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
Calamine, Pramoxind HCl	CALAMINE, PRAMOXIND HCL	H E B	4a7a0b09-d9bc-e752-e063-6394a90a9f2c	2026-06-15	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine, Zinc Oxide	CALAMINE, ZINC OXIDE	H E B	4a79259e-64ac-d187-e063-6294a90a78db	2026-06-15	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1	2026-06-11	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9	2026-06-11	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 rxcui: 904475 unii: 3M8608UQ61
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	3686a2df-51c4-4f1c-9d1e-d69207915144	2026-06-11	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	14390bfa-3bcb-43e1-936c-1977cb37427d	2026-06-04	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	8d1bf7a5-bf11-47e3-afca-dcc13f2d3068	2026-06-04	Warnings, Adverse reactions	Exact identifier application number: ANDA076341 rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	d0641def-425e-4357-a6b6-24ce00424549	2026-06-01	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	dcf46d0c-87da-4009-b238-eb5cf287c3ed	2026-05-29	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
Calamine	CALAMINE AND ZINC OXIDE	Pharma Nobis, LLC	fbcfa541-beda-06de-e053-6294a90a9298	2026-05-26	Warnings	Exact identifier unii: 1K09F3G675
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	2ded7e5e-c377-4495-a045-f1c57b90c5db	2026-05-21	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	46fdf929-c961-4dd9-8865-8eb4adaa259a	2026-05-21	Warnings, Adverse reactions	Exact identifier rxcui: 904475 unii: 3M8608UQ61
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	daacdad5-f75d-4f9f-b623-8071f3bef91e	2026-05-19	Warnings, Adverse reactions	Exact identifier rxcui: 904467 unii: 3M8608UQ61
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

Reported adverse events (FAERS/openFDA)#

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