Benztropine Mesylate

Product NDC
10135-608
11-digit product format
101350608
Labeler code
10135
Product ID
10135-608_9548ae2a-05b0-4810-a8ca-4f22413712c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA090168
Marketing category
ANDA
Marketing start
2017-12-15
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
2020-12-31
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
10135-608-012021-01-29C16284748780-1ba0f9c33-3b4c-a910-e053-dadaa90a0b85Benztropine Mesylate
10135-608-102021-01-29C16284748780-1ba0f9c33-3b4c-a910-e053-dadaa90a0b85Benztropine Mesylate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-608-01Benztropine Mesylate100 in 1 BOTTLE, PLASTICTABLET1006
10135-608-10Benztropine Mesylate1000 in 1 BOTTLE, PLASTICTABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-608-01EA - Each10135-6080dcfb901-f2a3-4cae-a6e0-d616422d560912016-03-04
10135-608-10EA - Each10135-6085de99277-9ec5-47ef-9c10-75b773f7563e12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-608BENZTROPINE MESYLATE TABLET [MARLEX PHARMACEUTICALS INC]6Legacy NDC, 2 package rows20190518_e653f9bc-40db-4048-bcf2-6fa46db85895.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSNe653f9bc-40db-4048-bcf2-6fa46db858956
885213benztropine mesylate 1 MG Oral TabletPSNe653f9bc-40db-4048-bcf2-6fa46db858956
885209benztropine mesylate 2 MG Oral TabletPSNe653f9bc-40db-4048-bcf2-6fa46db858956
885219benztropine mesylate 0.5 MG Oral TabletSCDe653f9bc-40db-4048-bcf2-6fa46db858956
885213benztropine mesylate 1 MG Oral TabletSCDe653f9bc-40db-4048-bcf2-6fa46db858956
885209benztropine mesylate 2 MG Oral TabletSCDe653f9bc-40db-4048-bcf2-6fa46db858956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-608-0110135060801100 in 1 BOTTLE, PLASTICHistorical
10135-608-10101350608101000 in 1 BOTTLE, PLASTICHistorical