Benztropine Mesylate

Product NDC
67046-0041
11-digit product format
670460041
Labeler code
67046
Product ID
67046-0041_50354b08-fe56-fdca-e063-6394a90a1cdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA040715
Marketing category
ANDA
Marketing start
2026-04-24
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
67046-0041-3Benztropine Mesylate30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSN5035534e-e15c-8f06-e063-6294a90a50031
885213benztropine mesylate 1 MG Oral TabletSCD5035534e-e15c-8f06-e063-6294a90a50031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-0041-36704600410330 TABLET in 1 BLISTER PACK (67046-0041-3) 30 tablet2026-04-24NoNoCurrent