FDA.reportPublic FDA data

BENZTROPINE MESYLATE

Product NDC
10135-813
11-digit product format
101350813
Labeler code
10135
Product ID
10135-813_31bbcbfa-dc75-99e2-e063-6394a90aa608
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Marlex PHARMACEUTICAL, INC
Application
ANDA204713
Marketing category
ANDA
Marketing start
2025-03-01
Substance
BENZTROPINE MESYLATE
Active strength
.5 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 MESYLATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWMJ8TL7510
Rxcui885209, 885213, 885219

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
10135-813-01BENZTROPINE MESYLATE100 in 1 BOTTLETABLET1001
10135-813-10BENZTROPINE MESYLATE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-813-01EA - Each10135-8135e2cd14e-f836-4f1f-bac8-8e0f27a19ac312025-06-13
10135-813-10EA - Each10135-813ee265661-e0f0-410d-b0f9-a47576e7a54c12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-813BENZTROPINE MESYLATE TABLET [MARLEX PHARMACEUTICAL, INC]1Current NDC, 2 package rows20250406_31bbcbfa-dc74-99e2-e063-6394a90aa608.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSN31bbcbfa-dc74-99e2-e063-6394a90aa6081
885213benztropine mesylate 1 MG Oral TabletPSN31bbcbfa-dc74-99e2-e063-6394a90aa6081
885209benztropine mesylate 2 MG Oral TabletPSN31bbcbfa-dc74-99e2-e063-6394a90aa6081
885219benztropine mesylate 0.5 MG Oral TabletSCD31bbcbfa-dc74-99e2-e063-6394a90aa6081
885213benztropine mesylate 1 MG Oral TabletSCD31bbcbfa-dc74-99e2-e063-6394a90aa6081
885209benztropine mesylate 2 MG Oral TabletSCD31bbcbfa-dc74-99e2-e063-6394a90aa6081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10135-813-0110135081301100 TABLET in 1 BOTTLE (10135-813-01) 100 tablet2025-03-01NoNoCurrent
10135-813-10101350813101000 TABLET in 1 BOTTLE (10135-813-10) 1000 tablet2025-03-01NoNoCurrent