BENZTROPINE MESYLATE

Product NDC
21695-286
11-digit product format
216950286
Labeler code
21695
Product ID
21695-286_ecb65310-e54e-48f8-a61b-4177bac41252
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA072266
Marketing category
ANDA
Marketing start
2002-08-13
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
2 mg/1
Pharmacologic classes
Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-286-302019-09-24C16284748780-1934fe258-4be1-48b1-e053-8cdaa90a720aBENZTROPINE MESYLATE TABLETS USP 0.5 mg, 1 mg and 2 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-286-30BENZTROPINE MESYLATE30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-286-30EA - Each21695-28624788bba-5830-4b12-9e9f-6fd837ce625112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [REBEL DISTRIBUTORS CORP]1
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBENZTROPINE MESYLATE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENZTROPINE MESYLATE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-286BENZTROPINE MESYLATE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110407_ecb65310-e54e-48f8-a61b-4177bac41252.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885209benztropine mesylate 2 MG Oral TabletPSNecb65310-e54e-48f8-a61b-4177bac412521
885209benztropine mesylate 2 MG Oral TabletSCDecb65310-e54e-48f8-a61b-4177bac412521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-286-302169502863030 in 1 BOTTLE, PLASTICHistorical