ROFLUMILAST

Product NDC: 42571-369
11-digit product format: 425710369
Labeler code: 42571
Product ID: 42571-369_3aacb2a6-70a4-650d-e063-6394a90af9fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROFLUMILAST
Dosage form: TABLET
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA208180
Marketing category: ANDA
Marketing start: 2023-05-01
Substance: ROFLUMILAST
Active strength: 250 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

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
A208180-001	ROFLUMILAST	ROFLUMILAST	500MCG	TABLET / ORAL	AB		2019-03-22
A208180-002	ROFLUMILAST	ROFLUMILAST	250MCG	TABLET / ORAL	AB		2023-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208180-001	AB
A208180-002	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 · 63 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	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208180-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL		2019-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208180-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2019-03-22	`b00525d2431f…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 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	A208180-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208180-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208180-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208180-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208180-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208180-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208180-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208180-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208180-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208180-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208180-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208180-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208180-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208180-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208180-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208180-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208180-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208180-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208180-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208180-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208180-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208180-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208180-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208180-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208180-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208180-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208180-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208180-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A208180-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A208180-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208180-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208180-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208180-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208180-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208180-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208180-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208180-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208180-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208180-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208180-002	AB	1	`a72a2bbeb626…`

Additional Listing Data#

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

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
dc2a689f-cfa4-4863-9623-a9813dcf86a9	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
42571-369-05	ROFLUMILAST	500 in 1 BOTTLE	TABLET	500	6
42571-369-11	ROFLUMILAST	10 in 1 CARTON	TABLET	10	6
42571-369-30	ROFLUMILAST	30 in 1 BOTTLE	TABLET	30	6
42571-369-32	ROFLUMILAST	10 in 1 BLISTER PACK	TABLET	10	6
42571-369-83	ROFLUMILAST	28 in 1 BOTTLE	TABLET	28	6
42571-369-90	ROFLUMILAST	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-369-83	EA - Each	42571-369	fbee6b5d-92a1-4be4-9007-aba0444c7ee7	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-369	ROFLUMILAST TABLET ROFLUMILAST TABLET [MICRO LABS LIMITED]	5	Current NDC, 6 package rows	20230502_dc2a689f-cfa4-4863-9623-a9813dcf86a9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROFLUMILAST	ROFLUMILAST	Micro Labs Limited	dc2a689f-cfa4-4863-9623-a9813dcf86a9	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208180 application number: ANDA208180 ndc (product): 42571-369
ROFLUMILAST	ROFLUMILAST	Bryant Ranch Prepack	fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208180 application number: ANDA208180

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	dc2a689f-cfa4-4863-9623-a9813dcf86a9	6
1091839	roflumilast 500 MCG Oral Tablet	PSN	dc2a689f-cfa4-4863-9623-a9813dcf86a9	6
2001319	roflumilast 0.25 MG Oral Tablet	SCD	dc2a689f-cfa4-4863-9623-a9813dcf86a9	6
1091839	roflumilast 0.5 MG Oral Tablet	SCD	dc2a689f-cfa4-4863-9623-a9813dcf86a9	6
2001319	roflumilast 250 MCG Oral Tablet	SY	dc2a689f-cfa4-4863-9623-a9813dcf86a9	6
1091839	roflumilast 500 MCG Oral Tablet	SY	dc2a689f-cfa4-4863-9623-a9813dcf86a9	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42571-369-05	42571036905	500 TABLET in 1 BOTTLE (42571-369-05)	500 tablet	2023-05-01	No	No	Current
42571-369-11	42571036911	10 BLISTER PACK in 1 CARTON (42571-369-11) / 10 TABLET in 1 BLISTER PACK (42571-369-32)	10 blister pack	2023-05-01	No	No	Current
42571-369-30	42571036930	30 TABLET in 1 BOTTLE (42571-369-30)	30 tablet	2023-05-01	No	No	Current
42571-369-32	42571036932	10 in 1 BLISTER PACK					Historical
42571-369-83	42571036983	28 TABLET in 1 BOTTLE (42571-369-83)	28 tablet	2023-05-01	No	No	Current
42571-369-90	42571036990	90 TABLET in 1 BOTTLE (42571-369-90)	90 tablet	2023-05-01	No	No	Current