Roflumilast Tablets, for oral use

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 21:10:28

Label at a glance#

ProductRoflumilast

Active ingredientROFLUMILAST

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1674-3

Roflumilast Tablets, 500 mcg

30 tablets

Rx only

NDC 70771-1673-8

Roflumilast Tablets, 250 mcg

Blister pack of 28 tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2001319	roflumilast 250 MCG Oral Tablet	PSN	4
1091839	roflumilast 500 MCG Oral Tablet	PSN	4
2001319	roflumilast 0.25 MG Oral Tablet	SCD	4
1091839	roflumilast 0.5 MG Oral Tablet	SCD	4
2001319	roflumilast 250 MCG Oral Tablet	SY	4
1091839	roflumilast 500 MCG Oral Tablet	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ROFLUMILAST Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1673-2	Roflumilast	10 in 1 BLISTER PACK	TABLET	10	4
70771-1673-3	Roflumilast	2 in 1 CARTON	TABLET	2	4
70771-1673-8	Roflumilast	28 in 1 BLISTER PACK	TABLET	28	4
70771-1673-8	Roflumilast	1 in 1 CARTON	TABLET	1	4
70771-1674-3	Roflumilast	30 in 1 BOTTLE	TABLET	30	4
70771-1674-9	Roflumilast	90 in 1 BOTTLE	TABLET	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1673	ROFLUMILAST TABLET [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, 4 package rows	20240815_e87287bd-eae3-46c3-9072-04800aeabf40.zip
70771-1674	ROFLUMILAST TABLET [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, Legacy NDC, 2 package rows	20240815_e87287bd-eae3-46c3-9072-04800aeabf40.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Roflumilast
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLOXAMER 407
SILICON DIOXIDE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1673	70771-1673-8, 70771-1673-2, 70771-1673-3
70771-1674	70771-1674-3, 70771-1674-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ROFLUMILAST	0P6C6ZOP5U	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	2165RE0K14	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
ROFLUMILAST	0P6C6ZOP5U	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	2165RE0K14	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208303-001	ROFLUMILAST	ROFLUMILAST	500MCG	TABLET / ORAL	AB		2022-02-10
A208303-002	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
A208303-001	AB
A208303-002	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 · 57 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
2026-09-14 22:38:34	2026-08	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208303-002	ROFLUMILAST	250MCG	TABLET / ORAL	AB	2023-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208303-001	ROFLUMILAST	500MCG	TABLET / ORAL	AB	2022-02-10	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208303-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208303-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208303-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208303-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208303-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208303-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208303-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208303-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208303-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208303-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208303-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208303-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208303-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208303-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208303-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208303-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208303-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208303-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208303-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208303-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208303-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208303-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208303-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208303-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208303-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208303-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208303-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208303-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208303-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208303-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208303-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208303-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208303-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208303-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208303-001	AB	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208303-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208303-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208303-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208303-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208303-001	AB	1	`ea1830bbd6c7…`

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
Roflumilast	ROFLUMILAST	Zydus Lifesciences Limited	e87287bd-eae3-46c3-9072-04800aeabf40	2024-08-12		Exact identifier ndc (package): 70771-1674-9 ndc (package): 70771-1673-3 ndc (package): 70771-1673-8 ndc (package): 70771-1673-2 ndc (package): 70771-1674-3 ndc (product): 70771-1673 ndc (product): 70771-1674 ndc11 (package): 70771167409 ndc11 (package): 70771167303 ndc11 (package): 70771167302 ndc11 (package): 70771167403 ndc11 (package): 70771167308 spl id: eb40db9e-ddc1-4041-aac5-ff0f2c478fc6 spl set id: e87287bd-eae3-46c3-9072-04800aeabf40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.