FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
0904-7290
11-digit product format
009047290
Labeler code
0904
Product ID
0904-7290_84795729-e08a-4fd6-97e9-0c07f691d162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA040715
Marketing category
ANDA
Marketing start
2023-07-11
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
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 MESYLATE2 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
0904-7290-61Benztropine Mesylate1 in 1 BLISTER PACKTABLET13
0904-7290-61Benztropine Mesylate100 in 1 CARTONTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7290-61EA - Each0904-7290de7747a3-50b0-4fbc-ab76-fa6a4b9423dc12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7290BENZTROPINE MESYLATE TABLET [MAJOR PHARMACEUTICALS]3Current NDC, 2 package rows20250119_8b18b66c-2935-4304-8e20-ebf68dee5a1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSN8b18b66c-2935-4304-8e20-ebf68dee5a1a3
885213benztropine mesylate 1 MG Oral TabletPSN8b18b66c-2935-4304-8e20-ebf68dee5a1a3
885209benztropine mesylate 2 MG Oral TabletPSN8b18b66c-2935-4304-8e20-ebf68dee5a1a3
885219benztropine mesylate 0.5 MG Oral TabletSCD8b18b66c-2935-4304-8e20-ebf68dee5a1a3
885213benztropine mesylate 1 MG Oral TabletSCD8b18b66c-2935-4304-8e20-ebf68dee5a1a3
885209benztropine mesylate 2 MG Oral TabletSCD8b18b66c-2935-4304-8e20-ebf68dee5a1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7290-6100904729061100 BLISTER PACK in 1 CARTON (0904-7290-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2023-07-11NoNoHistorical