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 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
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 · 60 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
2026-02-19 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…`
2019-12-14 00:12 UTC	2019-12	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208236-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2018-10-03	`b00525d2431f…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`

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 · 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

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

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