FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
69097-826
11-digit product format
690970826
Labeler code
69097
Product ID
69097-826_3d362141-de53-4949-b9a5-34f2b7bb0e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA090294
Marketing category
ANDA
Marketing start
2016-06-29
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
69097-826-02Benztropine Mesylate30 in 1 BOTTLETABLET303
69097-826-07Benztropine Mesylate100 in 1 BOTTLETABLET1003
69097-826-15Benztropine Mesylate1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-826-07EA - Each69097-826998cfed6-4ca7-4df6-a587-3e8c51c7af5612016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-826BENZTROPINE MESYLATE (BENZTROPINE) TABLET [CIPLA USA INC.]3Current NDC, Legacy NDC, 3 package rows20200502_3d2732f9-b8a9-4e83-91e7-da616ddcb786.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSN3d2732f9-b8a9-4e83-91e7-da616ddcb7863
885213benztropine mesylate 1 MG Oral TabletPSN3d2732f9-b8a9-4e83-91e7-da616ddcb7863
885209benztropine mesylate 2 MG Oral TabletPSN3d2732f9-b8a9-4e83-91e7-da616ddcb7863
885219benztropine mesylate 0.5 MG Oral TabletSCD3d2732f9-b8a9-4e83-91e7-da616ddcb7863
885213benztropine mesylate 1 MG Oral TabletSCD3d2732f9-b8a9-4e83-91e7-da616ddcb7863
885209benztropine mesylate 2 MG Oral TabletSCD3d2732f9-b8a9-4e83-91e7-da616ddcb7863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-826-026909708260230 TABLET in 1 BOTTLE (69097-826-02) 30 tablet2016-06-290000-00-00NoNoCurrent
69097-826-0769097082607100 TABLET in 1 BOTTLE (69097-826-07) 100 tablet2016-06-290000-00-00NoNoCurrent
69097-826-15690970826151000 TABLET in 1 BOTTLE (69097-826-15) 1000 tablet2016-06-290000-00-00NoNoCurrent