Daliresp

Product NDC: 0310-0095
Requested package NDC: 0310-0095-95
11-digit product format: 003100095
Labeler code: 0310
Product ID: 0310-0095_11cd495f-c5cf-4076-b69c-af202ec2a8a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: roflumilast
Dosage form: TABLET
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA022522
Marketing category: NDA
Marketing start: 2015-07-01
Substance: ROFLUMILAST
Active strength: 500 ug/1
Pharmacologic classes: Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0310-0095	0310-0095-95	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

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

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-0095	0310-0095-95	D	Discontinued by firm		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-0095	0310-0095-95	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Product history page 1 of 3 · 82 observed 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
2026-02-19 14:30 UTC	2026-02	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022522-002	DALIRESP	250MCG	TABLET / ORAL		RLD	2018-01-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022522-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022522-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022522-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022522-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022522-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022522-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022522-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022522-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022522-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022522-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022522-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022522-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022522-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022522-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022522-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022522-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022522-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022522-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022522-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022522-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022522-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022522-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022522-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022522-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022522-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022522-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022522-001	AB	1	`b00525d2431f…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 318 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	8604064	2024-03-08	U-1115		2018-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022522-002	8618142	2024-03-08		Drug product	2018-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	8536206	2024-03-08	U-1115		2013-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	8604064	2024-03-08	U-1115		2014-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-001	8618142	2024-03-08		Drug product	2014-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022522-002	8536206	2024-03-08	U-1115		2018-03-14	`301d65b070ca…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022522-001	M-208	2020-08-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022522-001	D-171	2021-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022522-002	NS	2021-01-23	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022522-001	D-171	2021-01-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022522-002	NS	2021-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022522-001	D-171	2021-01-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022522-002	NS	2021-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022522-001	D-171	2021-01-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022522-002	NS	2021-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022522-001	M-208	2020-08-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022522-001	D-171	2021-01-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022522-002	NS	2021-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022522-001	M-208	2020-08-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022522-001	D-171	2021-01-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022522-002	NS	2021-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022522-001	M-208	2020-08-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022522-001	D-171	2021-01-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022522-002	NS	2021-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022522-001	M-208	2020-08-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022522-001	D-171	2021-01-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022522-002	NS	2021-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022522-001	M-208	2020-08-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022522-001	D-171	2021-01-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022522-002	NS	2021-01-23	`ea99ee380514…`

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 ndc (package): 0310-0095-95 ndc (product): 0310-0095 ndc11 (package): 00310009595

Additional Listing Data#

Finished product: Yes
Brand name base: Daliresp
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROFLUMILAST	500 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0P6C6ZOP5U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091839	Internal RxNorm lookup
1091843	Internal RxNorm lookup
2001319	Internal RxNorm lookup
2001321	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dcb8b904-8d4f-458b-b954-4eae028a2651	Product name	2	20250305
a1a743b6-f2e2-4044-a176-5c60c71ece24	Product name	1	20250102
6ac6be18-9820-1c07-b72b-a35dcf9d14c7	Product name	9	20240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0310-0095-30	Daliresp	30 in 1 BOTTLE, PLASTIC	TABLET	30	15
0310-0095-39	Daliresp	2 in 1 BLISTER PACK	TABLET	2	15
0310-0095-39	Daliresp	10 in 1 BOX, UNIT-DOSE	TABLET	10	15
0310-0095-90	Daliresp	90 in 1 BOTTLE, PLASTIC	TABLET	90	15
0310-0095-95	Daliresp	1 in 1 BLISTER PACK	TABLET	1	15
0310-0095-95	Daliresp	7 in 1 BOX, UNIT-DOSE	TABLET	7	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-0095-30	EA - Each	0310-0095	04d1a507-ac28-4375-bcae-4c85c24571c5	1	2015-07-20
0310-0095-39	EA - Each	0310-0095	5892fc47-1cee-4b7e-a956-0c2f43d9d9ba	1	2015-07-20
0310-0095-90	EA - Each	0310-0095	bb8995bc-285e-4a9c-ae63-45b0433b8224	1	2015-07-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-0095	DALIRESP (ROFLUMILAST) TABLET [ASTRAZENECA PHARMACEUTICALS LP]	14	Current NDC, Legacy NDC, 6 package rows	20241120_c9a1d0a8-581f-4f91-a2b8-f419192d0ebf.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0P6C6ZOP5U	ROFLUMILAST	162401-32-3	ROFLUMILAST

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2001321	Daliresp 250 MCG Oral Tablet	PSN	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
1091843	Daliresp 500 MCG Oral Tablet	PSN	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
2001319	roflumilast 250 MCG Oral Tablet	PSN	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
1091839	roflumilast 500 MCG Oral Tablet	PSN	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
2001321	roflumilast 0.25 MG Oral Tablet [Daliresp]	SBD	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
1091843	roflumilast 0.5 MG Oral Tablet [Daliresp]	SBD	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
2001319	roflumilast 0.25 MG Oral Tablet	SCD	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
1091839	roflumilast 0.5 MG Oral Tablet	SCD	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
2001321	Daliresp 0.25 MG Oral Tablet	SY	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
1091843	Daliresp 0.5 MG Oral Tablet	SY	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
2001321	Daliresp 250 MCG Oral Tablet	SY	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
1091843	Daliresp 500 MCG Oral Tablet	SY	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
2001319	roflumilast 250 MCG Oral Tablet	SY	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15
1091839	roflumilast 500 MCG Oral Tablet	SY	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-0095-95	00310009595	7 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0095-95) > 1 TABLET in 1 BLISTER PACK	7 blister pack	2015-07-01	0000-00-00	No	No	Current