FDA.reportPublic FDA data

BENZTROPINE MESYLATE

Product NDC
72162-2595
11-digit product format
721622595
Labeler code
72162
Product ID
72162-2595_36677fd5-dd41-445d-b912-49904af6ce6d
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
1 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 MESYLATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWMJ8TL7510
Rxcui885213

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
72162-2595-0BENZTROPINE MESYLATE1000 in 1 BOTTLETABLET1000100
72162-2595-1BENZTROPINE MESYLATE100 in 1 BOTTLETABLET100100
72162-2595-2BENZTROPINE MESYLATE100 in 1 BOTTLE, PLASTICTABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2595-0EA - Each72162-25956942aa6d-4027-41e8-b6b3-030cef44fb9512026-02-05
72162-2595-1EA - Each72162-2595018d2108-6e80-4853-8814-6e36eb86b78912026-02-05
72162-2595-2EA - Each72162-2595989672cf-29a7-4fce-9ca0-97ffce2e506112026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSN9270d14c-b885-4679-8871-6f2547450398100
885213benztropine mesylate 1 MG Oral TabletSCD9270d14c-b885-4679-8871-6f2547450398100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2595-0721622595001000 TABLET in 1 BOTTLE (72162-2595-0) 1000 tablet2026-01-07NoNoHistorical
72162-2595-172162259501100 TABLET in 1 BOTTLE (72162-2595-1) 100 tablet2026-01-07NoNoHistorical
72162-2595-272162259502100 TABLET in 1 BOTTLE, PLASTIC (72162-2595-2) 100 tablet2026-01-07NoNoHistorical