Benztropine Mesylate

Product NDC
53808-0211
11-digit product format
538080211
Labeler code
53808
Product ID
53808-0211_6652f325-aa55-42d6-98a9-8d3684bc3a7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA089059
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
1 mg/1
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
53808-0211-12019-10-21C16284748780-1956f9ecf-c7a7-621f-e053-dbdaa90a74adBENZTROPINE MESYLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0211-1Benztropine Mesylate30 in 1 BLISTER PACKTABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0211BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100326_0c4af880-ec99-4bbe-a250-903770dcd461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSN0c4af880-ec99-4bbe-a250-903770dcd4612
885213benztropine mesylate 1 MG Oral TabletSCD0c4af880-ec99-4bbe-a250-903770dcd4612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0211-15380802110130 in 1 BLISTER PACKHistorical