Daliresp

Product NDC: 55154-4625
11-digit product format: 551544625
Labeler code: 55154
Product ID: 55154-4625_c4271d86-cc5f-4ed0-bf0d-fefcd6aa1e77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: roflumilast
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health
Application: NDA022522
Marketing category: NDA
Marketing start: 2011-02-28
Marketing end: 0000-00-00
Substance: ROFLUMILAST
Active strength: 500 ug/1
Pharmacologic classes: Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55154-4625		D	Discontinued by firm		2026-08-03
excluded package	package	55154-4625	55154-4625-8	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022522-001	DALIRESP	ROFLUMILAST	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28
N022522-002	DALIRESP	ROFLUMILAST	250MCG	TABLET / ORAL	AB	RLD	2018-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022522-001	AB
N022522-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N022522-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022522-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daliresp	ROFLUMILAST	AstraZeneca Pharmaceuticals LP	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	2020-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022522 application number: NDA022522