BENZTROPINE MESYLATE

Product NDC
70752-124
11-digit product format
707520124
Labeler code
70752
Product ID
70752-124_073409b4-0ae6-43d5-804a-a15ca581ecd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
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
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
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
70752-124-10BENZTROPINE MESYLATE100 in 1 BOTTLE, PLASTICTABLET1004
70752-124-11BENZTROPINE MESYLATE1000 in 1 BOTTLE, PLASTICTABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-124-10EA - Each70752-124ba775005-2fe1-4962-af4f-b5a54d3119ee12025-08-11
70752-124-11EA - Each70752-124cccb8fae-e0ea-4f2d-ae25-7eddd903e7a012025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-124BENZTROPINE MESYLATE TABLET [QUAGEN PHARMACEUTICALS LLC]3Current NDC, 2 package rows20250322_e1f0a249-e660-4592-9ffc-1c02b1022778.zip

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
885219benztropine mesylate 0.5 MG Oral TabletPSNe1f0a249-e660-4592-9ffc-1c02b10227784
885213benztropine mesylate 1 MG Oral TabletPSNe1f0a249-e660-4592-9ffc-1c02b10227784
885209benztropine mesylate 2 MG Oral TabletPSNe1f0a249-e660-4592-9ffc-1c02b10227784
885219benztropine mesylate 0.5 MG Oral TabletSCDe1f0a249-e660-4592-9ffc-1c02b10227784
885213benztropine mesylate 1 MG Oral TabletSCDe1f0a249-e660-4592-9ffc-1c02b10227784
885209benztropine mesylate 2 MG Oral TabletSCDe1f0a249-e660-4592-9ffc-1c02b10227784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70752-124-1070752012410100 TABLET in 1 BOTTLE, PLASTIC (70752-124-10) 100 tablet2025-08-11NoNoCurrent
70752-124-11707520124111000 TABLET in 1 BOTTLE, PLASTIC (70752-124-11) 1000 tablet2025-08-11NoNoCurrent