Benztropine Mesylate

Product NDC
50090-7017
11-digit product format
500907017
Labeler code
50090
Product ID
50090-7017_cd6a411a-4612-4fc7-aca5-53dac08c30af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040715
Marketing category
ANDA
Marketing start
2022-03-17
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
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 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
50090-7017-0Benztropine Mesylate100 in 1 BOX, UNIT-DOSETABLET1001
50090-7017-0Benztropine Mesylate1 in 1 BLISTER PACKTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7017-0EA - Each50090-7017dfe29cf3-97b8-4101-860f-3798cf99390912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7017BENZTROPINE MESYLATE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240108_53b134eb-b341-4fe4-a3ca-90a7da011974.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSN53b134eb-b341-4fe4-a3ca-90a7da0119741
885213benztropine mesylate 1 MG Oral TabletSCD53b134eb-b341-4fe4-a3ca-90a7da0119741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7017-050090701700100 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-7017-0) / 1 TABLET in 1 BLISTER PACK100 blister pack2024-01-04NoNoCurrent