BENZTROPINE MESYLATE

Product NDC
53808-0210
11-digit product format
538080210
Labeler code
53808
Product ID
53808-0210_d977e7ce-4bbb-42ba-aad5-ac46ef656206
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA072265
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
53808-0210-12019-10-21C16284748780-1956f9ecf-cc57-621f-e053-dbdaa90a74adBENZTROPINE MESYLATE TABLETS USP 0.5 mg, 1 mg and 2 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0210-1BENZTROPINE MESYLATE30 in 1 BLISTER PACKTABLET302

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0210BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100326_293d9505-b688-43dd-8b34-507e6a1c0fd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSN293d9505-b688-43dd-8b34-507e6a1c0fd32
885213benztropine mesylate 1 MG Oral TabletSCD293d9505-b688-43dd-8b34-507e6a1c0fd32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0210-15380802100130 in 1 BLISTER PACKHistorical