FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
50228-225
11-digit product format
502280225
Labeler code
50228
Product ID
50228-225_380cce0a-91d5-4c6e-80b0-e2b326264727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA040103
Marketing category
ANDA
Marketing start
2024-11-05
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
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 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
50228-225-01Benztropine Mesylate100 in 1 BOTTLETABLET1003
50228-225-10Benztropine Mesylate1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-225-01EA - Each50228-2252cb38324-5066-403f-a2cb-8fb3fcd38d7c12024-12-10
50228-225-10EA - Each50228-225abf8b650-829c-4dfc-a015-11526cf6a72612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-225BENZTROPINE MESYLATE TABLET [SCIEGEN PHARMACEUTICALS INC]2Current NDC, 2 package rows20241108_1ead16a7-88ed-407d-b25a-0d9a1d9da5ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSN1ead16a7-88ed-407d-b25a-0d9a1d9da5ef3
885213benztropine mesylate 1 MG Oral TabletPSN1ead16a7-88ed-407d-b25a-0d9a1d9da5ef3
885209benztropine mesylate 2 MG Oral TabletPSN1ead16a7-88ed-407d-b25a-0d9a1d9da5ef3
885219benztropine mesylate 0.5 MG Oral TabletSCD1ead16a7-88ed-407d-b25a-0d9a1d9da5ef3
885213benztropine mesylate 1 MG Oral TabletSCD1ead16a7-88ed-407d-b25a-0d9a1d9da5ef3
885209benztropine mesylate 2 MG Oral TabletSCD1ead16a7-88ed-407d-b25a-0d9a1d9da5ef3
885219benztropine mesylate 0.5 MG Oral TabletPSN50c61b1d-49d6-37f2-e063-6294a90a05901
885219benztropine mesylate 0.5 MG Oral TabletSCD50c61b1d-49d6-37f2-e063-6294a90a05901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50228-225-0150228022501100 TABLET in 1 BOTTLE (50228-225-01) 100 tablet2024-11-05NoNoHistorical
50228-225-10502280225101000 TABLET in 1 BOTTLE (50228-225-10) 1000 tablet2024-11-05NoNoHistorical