BENZTROPINE MESYLATE

Product NDC
61919-128
11-digit product format
619190128
Labeler code
61919
Product ID
61919-128_4d3fa8d2-31a0-759a-e063-6294a90a0267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040715
Marketing category
ANDA
Marketing start
2014-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BENZTROPINE MESYLATE
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-128-302023-01-30C16284748780-1f386c649-f443-0266-e053-dadaa90a7c1aBENZTROPINE MESYLATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-128-30BENZTROPINE MESYLATE30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-128BENZTROPINE MESYLATE TABLET [DIRECT RX]3Current NDC, Legacy NDC, 1 package rows20200118_9b93035b-34d6-4084-ba73-5dea72f9d124.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885209benztropine mesylate 2 MG Oral TabletPSN9b93035b-34d6-4084-ba73-5dea72f9d1244
885209benztropine mesylate 2 MG Oral TabletSCD9b93035b-34d6-4084-ba73-5dea72f9d1244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-128-306191901283030 TABLET in 1 BOTTLE (61919-128-30) 30 tablet2015-01-010000-00-00NoNoCurrent