BENZTROPINE MESYLATE

Product NDC
71335-0665
11-digit product format
713350665
Labeler code
71335
Product ID
71335-0665_55f99a9e-0761-41cf-a216-a6cbc7ac9b7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090168
Marketing category
ANDA
Marketing start
2014-01-31
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
No
Listing certified through
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0665-1BENZTROPINE MESYLATE30 in 1 BOTTLETABLET304
71335-0665-2BENZTROPINE MESYLATE60 in 1 BOTTLETABLET604
71335-0665-3BENZTROPINE MESYLATE90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0665BENZTROPINE MESYLATE TABLET [BRYANT RANCH PREPACK]4Legacy NDC, 3 package rows20220129_55f99a9e-0761-41cf-a216-a6cbc7ac9b7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSN55f99a9e-0761-41cf-a216-a6cbc7ac9b7d4
885213benztropine mesylate 1 MG Oral TabletSCD55f99a9e-0761-41cf-a216-a6cbc7ac9b7d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0665-17133506650130 TABLET in 1 BOTTLE (71335-0665-1) 30 tablet2021-12-270000-00-00NoNoCurrent
71335-0665-27133506650260 TABLET in 1 BOTTLE (71335-0665-2) 60 tablet2021-12-270000-00-00NoNoCurrent
71335-0665-37133506650390 TABLET in 1 BOTTLE (71335-0665-3) 90 tablet2018-03-210000-00-00NoNoCurrent