BENZTROPINE MESYLATE

Product NDC
63187-840
11-digit product format
631870840
Labeler code
63187
Product ID
63187-840_6d5cf36c-417b-4b36-b570-2a757b516246
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090168
Marketing category
ANDA
Marketing start
2012-11-28
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
63187-840-03BENZTROPINE MESYLATE03 in 1 BOTTLETABLET033
63187-840-30BENZTROPINE MESYLATE30 in 1 BOTTLETABLET303
63187-840-60BENZTROPINE MESYLATE90 in 1 BOTTLETABLET903
63187-840-90BENZTROPINE MESYLATE60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-840-03EA - Each63187-8400d02c9cf-5759-4913-b48b-a0fe1bee7e5c12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-840BENZTROPINE MESYLATE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20191113_c1044563-2bd2-4f43-a951-25d083b1c679.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSNc1044563-2bd2-4f43-a951-25d083b1c6793
885213benztropine mesylate 1 MG Oral TabletSCDc1044563-2bd2-4f43-a951-25d083b1c6793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-840-03631870840033 TABLET in 1 BOTTLE (63187-840-03) 3 tablet2017-05-010000-00-00NoNoCurrent
63187-840-306318708403030 TABLET in 1 BOTTLE (63187-840-30) 30 tablet2017-05-010000-00-00NoNoCurrent
63187-840-606318708406090 TABLET in 1 BOTTLE (63187-840-60) 90 tablet2017-05-010000-00-00NoNoCurrent
63187-840-906318708409060 TABLET in 1 BOTTLE (63187-840-90) 60 tablet2017-05-010000-00-00NoNoCurrent