Roflumilast

Product NDC: 67877-480
11-digit product format: 678770480
Labeler code: 67877
Product ID: 67877-480_955dd6eb-46f6-4c73-bcc8-bfd7b14ebc98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Roflumilast
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA212490
Marketing category: ANDA
Marketing start: 2025-03-14
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

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
A212490-001	ROFLUMILAST	ROFLUMILAST	250MCG	TABLET / ORAL	AB		2023-04-18
A212490-002	ROFLUMILAST	ROFLUMILAST	500MCG	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
A212490-001	AB
A212490-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-10-29 15:01 UTC	2024-10	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`3f0d92c62455…`
2026-08-01 22:54:32	2026-06	A212490-001	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A212490-002	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2023-04-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-10-29 15:01 UTC	2024-10	A212490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212490-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212490-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212490-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212490-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212490-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212490-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212490-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212490-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212490-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212490-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212490-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212490-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212490-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212490-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212490-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212490-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212490-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212490-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212490-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212490-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212490-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212490-002	AB	1	`3f0d92c62455…`
2026-08-01 22:54:32	2026-06	A212490-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A212490-002	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	Golden State Medical Supply, Inc.	30dd6eae-6435-cae1-e063-6294a90a003b	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212490 application number: ANDA212490
Roflumilast	ROFLUMILAST	Ascend Laboratories, LLC	93d72a99-64dc-4fde-a5b8-78331fa60787	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212490 application number: ANDA212490 ndc (product): 67877-480

Additional Listing Data#

Finished product: Yes
Brand name base: Roflumilast
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 · 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
93d72a99-64dc-4fde-a5b8-78331fa60787	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
67877-480-05	Roflumilast	500 in 1 BOTTLE	TABLET	500	5
67877-480-30	Roflumilast	30 in 1 BOTTLE	TABLET	30	5
67877-480-33	Roflumilast	10 in 1 BLISTER PACK	TABLET	10	5
67877-480-33	Roflumilast	1 in 1 CARTON	TABLET	1	5
67877-480-90	Roflumilast	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-480-90	EA - Each	67877-480	efdca2ea-a449-40d9-b821-1fdefdfef12f	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-480	ROFLUMILAST TABLET [ASCEND LABORATORIES, LLC]	5	Current NDC, 5 package rows	20250316_93d72a99-64dc-4fde-a5b8-78331fa60787.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
2001319	roflumilast 250 MCG Oral Tablet	PSN	93d72a99-64dc-4fde-a5b8-78331fa60787	5
1091839	roflumilast 500 MCG Oral Tablet	PSN	93d72a99-64dc-4fde-a5b8-78331fa60787	5
2001319	roflumilast 0.25 MG Oral Tablet	SCD	93d72a99-64dc-4fde-a5b8-78331fa60787	5
1091839	roflumilast 0.5 MG Oral Tablet	SCD	93d72a99-64dc-4fde-a5b8-78331fa60787	5
2001319	roflumilast 250 MCG Oral Tablet	SY	93d72a99-64dc-4fde-a5b8-78331fa60787	5
1091839	roflumilast 500 MCG Oral Tablet	SY	93d72a99-64dc-4fde-a5b8-78331fa60787	5
1091839	roflumilast 500 MCG Oral Tablet	PSN	30dd6eae-6435-cae1-e063-6294a90a003b	1
1091839	roflumilast 0.5 MG Oral Tablet	SCD	30dd6eae-6435-cae1-e063-6294a90a003b	1
1091839	roflumilast 500 MCG Oral Tablet	SY	30dd6eae-6435-cae1-e063-6294a90a003b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67877-480-05	67877048005	500 TABLET in 1 BOTTLE (67877-480-05)	500 tablet	2025-03-14	No	No	Current
67877-480-30	67877048030	30 TABLET in 1 BOTTLE (67877-480-30)	30 tablet	2025-03-14	No	No	Current
67877-480-33	67877048033	1 BLISTER PACK in 1 CARTON (67877-480-33) / 10 TABLET in 1 BLISTER PACK	1 blister pack	2025-03-14	No	No	Current
67877-480-90	67877048090	90 TABLET in 1 BOTTLE (67877-480-90)	90 tablet	2025-03-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Roflumilast	Golden State Medical Supply, Inc.	2025-03-21	HUMAN PRESCRIPTION DRUG LABEL	1
Roflumilast	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2025-03-13	Human Prescription Drug Label	5