Benztropine Mesylate

Product NDC
64725-0012
11-digit product format
647250012
Labeler code
64725
Product ID
64725-0012_9573c6b0-a783-4559-8e44-74ee89fc28a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine Mesylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
TYA Pharmaceuticals
Application
NDA012015
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-08-08
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
1 mg/mL
Pharmacologic classes
Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2961cf47-535c-c402-c24d-0a9130269674Product name320251121
3f930a8b-cc65-fba9-e4ca-58b6abcea16bProduct name220220509

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0012-12020-01-31C16284748780-19d75b9d1-1500-f424-e053-dadaa90a57ceBenztropine Mesylate Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0012-1Benztropine Mesylate5 mL in 1 CARTONINJECTION52

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benztropine MesylateACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS]2
BenztropineACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0012BENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141031_d61eae0d-a29d-45ef-bd41-07123e0c21f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885205benztropine mesylate 2 MG in 2 ML InjectionPSNd61eae0d-a29d-45ef-bd41-07123e0c21f92
8852052 ML benztropine mesylate 1 MG/ML InjectionSCDd61eae0d-a29d-45ef-bd41-07123e0c21f92
885205benztropine mesylate 2 MG per 2 ML InjectionSYd61eae0d-a29d-45ef-bd41-07123e0c21f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-0012-1647250012015 mL in 1 CARTON5 mlHistorical