Roflumilast

Product NDC: 59746-801
11-digit product format: 597460801
Labeler code: 59746
Product ID: 59746-801_aaa81c1b-f63d-4e61-8bfa-9d42d92043c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: roflumilast
Dosage form: TABLET
Route: ORAL
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Application: ANDA208236
Marketing category: ANDA
Marketing start: 2026-02-02
Substance: ROFLUMILAST
Active strength: 250 ug/1
Pharmacologic classes: Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A208236-001	ROFLUMILAST	ROFLUMILAST	500MCG	TABLET / ORAL	AB		2018-10-03
A208236-002	ROFLUMILAST	ROFLUMILAST	250MCG	TABLET / ORAL	AB		2023-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208236-001	AB
A208236-002	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 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL		2023-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208236-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL		2018-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-10-03	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208236-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208236-002	AB	1	`caaa826d4ba7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208236-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208236-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208236-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A208236-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208236-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208236-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208236-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208236-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208236-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208236-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208236-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208236-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208236-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208236-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208236-002	AB	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208236-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208236-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Roflumilast
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROFLUMILAST	250 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091839	Internal RxNorm lookup
2001319	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
aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	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	Strength	SPL version
59746-801-70	Roflumilast	28 in 1 BLISTER PACK	TABLET	28		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-801-70	EA - Each	59746-801	be5be18f-ab73-4f13-8b6f-9df65ee4e655	1	2026-03-17

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Roflumilast	ROFLUMILAST	Jubilant Cadista Pharmaceuticals Inc.	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208236 application number: ANDA208236 ndc (product): 59746-801
ROFLUMILAST	ROFLUMILAST	Amici Pharma Inc.	cb3781ff-5350-4f9a-b247-0b04eb0f2b92	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208236 application number: ANDA208236

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
2001319	roflumilast 250 MCG Oral Tablet	PSN	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	1
1091839	roflumilast 500 MCG Oral Tablet	PSN	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	1
2001319	roflumilast 0.25 MG Oral Tablet	SCD	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	1
1091839	roflumilast 0.5 MG Oral Tablet	SCD	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	1
2001319	roflumilast 250 MCG Oral Tablet	SY	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	1
1091839	roflumilast 500 MCG Oral Tablet	SY	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59746-801-70	59746080170	28 TABLET in 1 BLISTER PACK (59746-801-70)	28 tablet	2026-02-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Roflumilast	Jubilant Cadista Pharmaceuticals Inc. \| Aavis Pharmaceuticals Inc.	2026-07-14	Human Prescription Drug Label	3