FDA.reportPublic FDA data

BENZTROPINE MESYLATE

Product NDC
11534-169
11-digit product format
115340169
Labeler code
11534
Product ID
11534-169_192d20d2-c01e-4150-beb0-03f8da966acc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
SUNRISE PHARMACEUTICAL, INC
Application
ANDA204713
Marketing category
ANDA
Marketing start
2024-10-16
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
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 MESYLATE2 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
11534-169-09BENZTROPINE MESYLATE100 in 1 BOTTLETABLET1002
11534-169-10BENZTROPINE MESYLATE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-169-01EA - Each11534-169c8039670-a122-4250-93d9-685a766e57c812015-10-02
11534-169-03EA - Each11534-169dc5deedc-9864-45a8-9bde-4c4ed00d275912015-10-02
11534-169-09EA - Each11534-1698688c2be-4a5b-498d-a84c-0daa8355da3212024-12-10
11534-169-10EA - Each11534-169e59ef381-684b-4b55-b423-e04047d114e712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-169BENZTROPINE MESYLATE TABLET [SUNRISE PHARMACEUTICAL, INC]2Current NDC, 2 package rows20241018_2c988462-ce77-4e99-b98e-8f6ad519e295.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSN2c988462-ce77-4e99-b98e-8f6ad519e2952
885213benztropine mesylate 1 MG Oral TabletPSN2c988462-ce77-4e99-b98e-8f6ad519e2952
885209benztropine mesylate 2 MG Oral TabletPSN2c988462-ce77-4e99-b98e-8f6ad519e2952
885219benztropine mesylate 0.5 MG Oral TabletSCD2c988462-ce77-4e99-b98e-8f6ad519e2952
885213benztropine mesylate 1 MG Oral TabletSCD2c988462-ce77-4e99-b98e-8f6ad519e2952
885209benztropine mesylate 2 MG Oral TabletSCD2c988462-ce77-4e99-b98e-8f6ad519e2952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11534-169-0911534016909100 TABLET in 1 BOTTLE (11534-169-09) 100 tablet2024-10-16NoNoCurrent
11534-169-10115340169101000 TABLET in 1 BOTTLE (11534-169-10) 1000 tablet2024-10-16NoNoCurrent