FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
62135-141
11-digit product format
621350141
Labeler code
62135
Product ID
62135-141_458c005f-8842-3916-e063-6294a90a93b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA081265
Marketing category
ANDA
Marketing start
1992-01-23
Substance
BENZTROPINE MESYLATE
Active strength
.5 mg/1
Pharmacologic classes
Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benztropine Mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZTROPINE MESYLATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWMJ8TL7510
Rxcui885209, 885213, 885219

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2961cf47-535c-c402-c24d-0a9130269674Product name320251121
3f930a8b-cc65-fba9-e4ca-58b6abcea16bProduct name220220509

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-141-18Benztropine Mesylate180 in 1 BOTTLETABLET1806
62135-141-57Benztropine Mesylate540 in 1 BOTTLETABLET5406

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-141BENZTROPINE MESYLATE TABLET [CHARTWELL RX, LLC.]5Current NDC, 2 package rows20241016_c002005d-a478-48d4-b345-cb87edcb061f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSNc002005d-a478-48d4-b345-cb87edcb061f6
885213benztropine mesylate 1 MG Oral TabletPSNc002005d-a478-48d4-b345-cb87edcb061f6
885209benztropine mesylate 2 MG Oral TabletPSNc002005d-a478-48d4-b345-cb87edcb061f6
885219benztropine mesylate 0.5 MG Oral TabletSCDc002005d-a478-48d4-b345-cb87edcb061f6
885213benztropine mesylate 1 MG Oral TabletSCDc002005d-a478-48d4-b345-cb87edcb061f6
885209benztropine mesylate 2 MG Oral TabletSCDc002005d-a478-48d4-b345-cb87edcb061f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-141-1862135014118180 TABLET in 1 BOTTLE (62135-141-18) 180 tablet2022-09-01NoNoCurrent
62135-141-5762135014157540 TABLET in 1 BOTTLE (62135-141-57) 540 tablet2022-09-01NoNoCurrent