Daliresp

Product NDC: 0310-0095
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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 package	package	0310-0095	0310-0095-39	D	Discontinued by firm		2026-08-17
excluded package	package	0310-0095	0310-0095-95	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0310-0095-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0310-0095-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0310-0095-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0310-0095-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0310-0095-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0310-0095-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0310-0095-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0310-0095-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0310-0095-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0310-0095-95	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0310-0095-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0310-0095-95	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0310-0095-39	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0310-0095-95	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0310-0095-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0310-0095-95	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0310-0095-39	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0310-0095-95	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0310-0095-95	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0310-0095-39	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0310-0095-95	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0310-0095-39	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0310-0095-95	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0310-0095-39	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 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
2026-08-18 06:07:40	2026-07	N022522-001	DALIRESP	500MCG	TABLET / ORAL	AB	RLD, RS	2011-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022522-002	DALIRESP	250MCG	TABLET / ORAL	AB	RLD	2018-01-23	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022522-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022522-002	AB	1	`caaa826d4ba7…`
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…`

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…`

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

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 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 (product): 0310-0095

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
0310-0095-30	00310009530	30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)	30 tablet	2015-07-01	0000-00-00	No	No	Current
0310-0095-39	00310009539	2 in 1 BLISTER PACK						Historical
0310-0095-90	00310009590	90 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90)	90 tablet	2015-07-01	0000-00-00	No	No	Current
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