Motofen

Product NDC: 83107-011
Requested package NDC: 83107-011-10
11-digit product format: 831070011
Labeler code: 83107
Product ID: 83107-011_4db25dab-3394-5f06-e063-6294a90a9688
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: difenoxin and atropine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Legacy Pharma USA Inc.
Application: NDA017744
Marketing category: NDA
Marketing start: 2026-01-01
Substance: DIFENOXIN HYDROCHLORIDE; ATROPINE SULFATE
Active strength: 1; .025 mg/1; mg/1
Pharmacologic classes: Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule: CIV
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 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
N017744-001	MOTOFEN HALF-STRENGTH	ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE	0.025MG;0.5MG	TABLET / ORAL		Approved before 1982
N017744-002	MOTOFEN	ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE	0.025MG;1MG	TABLET / ORAL		RLD, RS, Approved before 1982

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017744-001	MOTOFEN HALF-STRENGTH	0.025MG;0.5MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017744-002	MOTOFEN	0.025MG;1MG	TABLET / ORAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIFENOXIN HYDROCHLORIDE	1 mg/1
ATROPINE SULFATE	.025 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VQZ63K01IW	Internal UNII lookup
03J5ZE7KA5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1190738	Internal RxNorm lookup
1190740	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
1fa11c67-5492-469c-9475-6bfa0e5e9ff8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822	Product name	4	20250801
41231c1e-8789-4da7-ac52-77fa90a85bf5	Product name	2	20250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0	Product name	2	20250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407	Product name	4	20240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
d3908afb-7784-440f-c406-88294732d36a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83107-011-10	Motofen	100 in 1 BOTTLE	TABLET	100		2

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
Motofen	DIFENOXIN AND ATROPINE SULFATE	Legacy Pharma USA Inc.	1fa11c67-5492-469c-9475-6bfa0e5e9ff8	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017744 application number: NDA017744 ndc (package): 83107-011-10 ndc (product): 83107-011 ndc11 (package): 83107001110
Motofen	DIFENOXIN AND ATROPINE SULFATE	Sebela Pharmaceuticals Inc.	4cd3f029-a5e3-5812-e054-00144ff8d46c	2025-11-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017744 application number: NDA017744

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VQZ63K01IW	DIFENOXIN HYDROCHLORIDE	35607-36-4	DIFENOXIN HYDROCHLORIDE
03J5ZE7KA5	ATROPINE SULFATE	5908-99-6	ATROPINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1190738	difenoxin 1 MG / atropine sulfate 0.025 MG Oral Tablet	PSN	1fa11c67-5492-469c-9475-6bfa0e5e9ff8	2
1190740	Motofen 1 MG / 0.025 MG Oral Tablet	PSN	1fa11c67-5492-469c-9475-6bfa0e5e9ff8	2
1190740	atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen]	SBD	1fa11c67-5492-469c-9475-6bfa0e5e9ff8	2
1190738	atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet	SCD	1fa11c67-5492-469c-9475-6bfa0e5e9ff8	2
1190740	Motofen (atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG) Oral Tablet	SY	1fa11c67-5492-469c-9475-6bfa0e5e9ff8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83107-011-10	83107001110	100 TABLET in 1 BOTTLE (83107-011-10)	100 tablet	2026-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Motofen ® (difenoxin and atropine sulfate tablets) CIV Rx Only	Legacy Pharma USA Inc.	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	2