BENZTROPINE MESYLATE

Product NDC
50090-3883
11-digit product format
500903883
Labeler code
50090
Product ID
50090-3883_fcd04c58-aea8-427f-8434-a1a9b86299fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090168
Marketing category
ANDA
Marketing start
2014-01-31
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
2 mg/1
Pharmacologic classes
Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2961cf47-535c-c402-c24d-0a9130269674Product name320251121
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3f930a8b-cc65-fba9-e4ca-58b6abcea16bProduct name220220509

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3883-02023-01-30C16284748780-1f386c64a-2c2e-0266-e053-dadaa90a7c1aBENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3883-0BENZTROPINE MESYLATE32 in 1 BOTTLETABLET323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3883BENZTROPINE MESYLATE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20200116_097c9f4b-2f5f-44e5-bf42-7ea93008e572.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885209benztropine mesylate 2 MG Oral TabletPSN097c9f4b-2f5f-44e5-bf42-7ea93008e5723
885209benztropine mesylate 2 MG Oral TabletSCD097c9f4b-2f5f-44e5-bf42-7ea93008e5723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3883-05009038830032 TABLET in 1 BOTTLE (50090-3883-0) 32 tablet2018-11-290000-00-00NoNoCurrent