Benztropine Mesylate

Product NDC
72162-1154
11-digit product format
721621154
Labeler code
72162
Product ID
72162-1154_0cd274ca-3c17-4d18-b7d2-31edd8f2c9cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040715
Marketing category
ANDA
Marketing start
2022-03-17
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

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
72162-1154-1Benztropine Mesylate100 in 1 BOTTLE, PLASTICTABLET100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1154BENZTROPINE MESYLATE TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20230531_959363b8-6847-4f6e-9957-6254febb085c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885209benztropine mesylate 2 MG Oral TabletPSN959363b8-6847-4f6e-9957-6254febb085c100
885209benztropine mesylate 2 MG Oral TabletSCD959363b8-6847-4f6e-9957-6254febb085c100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1154-172162115401100 TABLET in 1 BOTTLE, PLASTIC (72162-1154-1) 100 tablet2023-05-30NoNoCurrent