NDC 42571-369-32 - 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: 42571-369
Requested NDC: 42571-369-32
Package NDCs from labels: 42571-369-83, 42571-369-30, 42571-369-90, 42571-369-05, 42571-369-32, 42571-369-11
Manufacturer: Micro Labs Limited
Effective date: 2025-07-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ROFLUMILAST - Micro Labs Limited	Micro Labs Limited	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42571-369-05	ROFLUMILAST	500 in 1 BOTTLE	TABLET	500	6
42571-369-11	ROFLUMILAST	10 in 1 CARTON	TABLET	10	6
42571-369-30	ROFLUMILAST	30 in 1 BOTTLE	TABLET	30	6
42571-369-32	ROFLUMILAST	10 in 1 BLISTER PACK	TABLET	10	6
42571-369-83	ROFLUMILAST	28 in 1 BOTTLE	TABLET	28	6
42571-369-90	ROFLUMILAST	90 in 1 BOTTLE	TABLET	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-369	ROFLUMILAST TABLET ROFLUMILAST TABLET [MICRO LABS LIMITED]	5	Current NDC, 6 package rows	20230502_dc2a689f-cfa4-4863-9623-a9813dcf86a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-369-83	EA - Each	42571-369	fbee6b5d-92a1-4be4-9007-aba0444c7ee7	1	2023-07-06

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.