NDC 68071-3615-01 - Lovastatin

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: 68071-3615
Requested NDC: 68071-3615-01
Package NDCs from labels: 68071-3615-1, 68071-3615-01
Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2024-06-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3615-1	Lovastatin	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3615	LOVASTATIN TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20240620_19b2bb87-1dc7-cd72-e063-6394a90a0f73.zip

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 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	Proficient Rx LP	f9e27117-db98-48bc-b7bc-fc98c9b719cf	2019-11-01	Warnings, Adverse reactions	Exact identifier application number: ANDA078296 rxcui: 197903 unii: 9LHU78OQFD

Reported adverse events (FAERS/openFDA)#

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