FDA.reportPublic FDA data

Motofen

Product NDC
54766-200
11-digit product format
547660200
Labeler code
54766
Product ID
54766-200_43144b43-adf2-3d58-e063-6394a90a2b81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
difenoxin and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Sebela Pharmaceuticals Inc.
Application
NDA017744
Marketing category
NDA
Marketing start
2017-04-11
Marketing end
2028-08-31
Substance
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
Active strength
.025; 1 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Motofen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.025 mg/1
DIFENOXIN HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5, VQZ63K01IW
Rxcui1190738, 1190740

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54766-200-04Motofen4 in 1 BLISTER PACKTABLET44
54766-200-10Motofen100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-200-10EA - Each54766-2009d467e3a-3f75-4f3a-b5f1-af9c11b17c6712017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54766-200MOTOFEN (DIFENOXIN AND ATROPINE SULFATE) TABLET [SEBELA PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20181215_4cd3f029-a5e3-5812-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190738difenoxin 1 MG / atropine sulfate 0.025 MG Oral TabletPSN4cd3f029-a5e3-5812-e054-00144ff8d46c4
1190740Motofen 1 MG / 0.025 MG Oral TabletPSN4cd3f029-a5e3-5812-e054-00144ff8d46c4
1190740atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen]SBD4cd3f029-a5e3-5812-e054-00144ff8d46c4
1190738atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral TabletSCD4cd3f029-a5e3-5812-e054-00144ff8d46c4
1190740Motofen (atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG) Oral TabletSY4cd3f029-a5e3-5812-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54766-200-04547660200044 TABLET in 1 BLISTER PACK (54766-200-04) 4 tablet2017-04-110000-00-00YesNoCurrent
54766-200-1054766020010100 TABLET in 1 BOTTLE (54766-200-10) 100 tablet2017-04-112028-08-31NoNoCurrent