BENZTROPINE MESYLATE

Product NDC
72162-2596
11-digit product format
721622596
Labeler code
72162
Product ID
72162-2596_959a0659-677c-4d0d-a77d-bf41abd0cebc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212694
Marketing category
ANDA
Marketing start
2025-08-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BENZTROPINE MESYLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZTROPINE MESYLATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWMJ8TL7510
Rxcui885209

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
72162-2596-0BENZTROPINE MESYLATE1000 in 1 BOTTLETABLET1000100
72162-2596-1BENZTROPINE MESYLATE100 in 1 BOTTLETABLET100100
72162-2596-2BENZTROPINE MESYLATE100 in 1 BOTTLETABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2596-0EA - Each72162-2596eb40daa9-9716-4c53-8152-5d9506a599cc12026-02-05
72162-2596-1EA - Each72162-25969c16dce1-ada9-42c9-90e2-3a9f3ea0c04d12026-02-05
72162-2596-2EA - Each72162-2596f5fc34a6-6a8f-47d0-b966-030edb53019e12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885209benztropine mesylate 2 MG Oral TabletPSN284e78af-7544-4c4a-8081-74e45501dc76100
885209benztropine mesylate 2 MG Oral TabletSCD284e78af-7544-4c4a-8081-74e45501dc76100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2596-0721622596001000 TABLET in 1 BOTTLE (72162-2596-0) 1000 tablet2026-01-07NoNoHistorical
72162-2596-172162259601100 TABLET in 1 BOTTLE (72162-2596-1) 100 tablet2026-01-07NoNoHistorical
72162-2596-272162259602100 TABLET in 1 BOTTLE (72162-2596-2) 100 tablet2026-01-07NoNoHistorical