NDC 72162-2385-03 - ROFLUMILAST

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: 72162-2385
Requested NDC: 72162-2385-03
Package NDCs from labels: 72162-2385-3, 72162-2385-03
Manufacturer: Bryant Ranch Prepack
Effective date: 2024-08-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ROFLUMILAST - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2385-3	ROFLUMILAST	30 in 1 BOTTLE	TABLET	30		100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2385	ROFLUMILAST TABLET [BRYANT RANCH PREPACK]	100	Current NDC, 1 package rows	20240816_fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2385-3	EA - Each	72162-2385	f5ea082d-3408-43a6-bea0-9315162d26a8	1	2024-11-05

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Roflumilast	ROFLUMILAST	Camber Pharmaceuticals, Inc.	f25a0230-3cf6-4366-bebe-0ea5ff8de5ab	2023-04-28	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
ROFLUMILAST	ROFLUMILAST	Solco Healthcare US, LLC.	4251c764-7224-4f94-9de7-b6c76cb1f5cd	2022-05-10	Warnings, Adverse reactions	Exact identifier rxcui: 1091839 unii: 0P6C6ZOP5U
Daliresp	ROFLUMILAST	AstraZeneca Pharmaceuticals LP	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	2020-03-12	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U

Reported adverse events (FAERS/openFDA)#

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