FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
0603-2433
11-digit product format
006032433
Labeler code
0603
Product ID
0603-2433_f572eba2-cce7-4e65-9df4-9c0585530c0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA040715
Marketing category
ANDA
Marketing start
2022-03-17
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
0603-2433-10Benztropine Mesylate10 in 1 BOTTLE, PLASTICTABLET109
0603-2433-21Benztropine Mesylate100 in 1 BOTTLE, PLASTICTABLET1009
0603-2433-32Benztropine Mesylate1000 in 1 BOTTLE, PLASTICTABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-2433-21EA - Each0603-2433ed194a4f-8cbb-421b-ba46-6d8a3322f7f312012-07-24
0603-2433-32EA - Each0603-2433d2e9a1f6-a912-4d95-a0a0-3d114793e37312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JBENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-2433BENZTROPINE MESYLATE TABLET [ENDO USA, INC.]9Current NDC, Legacy NDC, 3 package rows20241212_c19664aa-a797-4192-b5f3-e906a7cac048.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSNb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885213benztropine mesylate 1 MG Oral TabletPSNb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885209benztropine mesylate 2 MG Oral TabletPSNb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885219benztropine mesylate 0.5 MG Oral TabletSCDb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885213benztropine mesylate 1 MG Oral TabletSCDb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885209benztropine mesylate 2 MG Oral TabletSCDb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885219benztropine mesylate 0.5 MG Oral TabletPSNdf0647b8-2aa7-4aa4-9ba3-82c28698e7c510
885213benztropine mesylate 1 MG Oral TabletPSNdf0647b8-2aa7-4aa4-9ba3-82c28698e7c510
885219benztropine mesylate 0.5 MG Oral TabletSCDdf0647b8-2aa7-4aa4-9ba3-82c28698e7c510
885213benztropine mesylate 1 MG Oral TabletSCDdf0647b8-2aa7-4aa4-9ba3-82c28698e7c510
885219benztropine mesylate 0.5 MG Oral TabletPSNc19664aa-a797-4192-b5f3-e906a7cac0489
885213benztropine mesylate 1 MG Oral TabletPSNc19664aa-a797-4192-b5f3-e906a7cac0489
885209benztropine mesylate 2 MG Oral TabletPSNc19664aa-a797-4192-b5f3-e906a7cac0489
885219benztropine mesylate 0.5 MG Oral TabletSCDc19664aa-a797-4192-b5f3-e906a7cac0489
885213benztropine mesylate 1 MG Oral TabletSCDc19664aa-a797-4192-b5f3-e906a7cac0489
885209benztropine mesylate 2 MG Oral TabletSCDc19664aa-a797-4192-b5f3-e906a7cac0489
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
885219benztropine mesylate 0.5 MG Oral TabletPSN512ada3e-4b85-d989-e063-6394a90a9d541
885219benztropine mesylate 0.5 MG Oral TabletPSN26a52fdf-3992-c1c1-e063-6294a90a80f71
885219benztropine mesylate 0.5 MG Oral TabletPSN806ff51f-38be-4bf9-adc7-61efb11b5a6b1
885213benztropine mesylate 1 MG Oral TabletPSN806ff51f-38be-4bf9-adc7-61efb11b5a6b1
885219benztropine mesylate 0.5 MG Oral TabletSCD806ff51f-38be-4bf9-adc7-61efb11b5a6b1
885219benztropine mesylate 0.5 MG Oral TabletSCD512ada3e-4b85-d989-e063-6394a90a9d541
885219benztropine mesylate 0.5 MG Oral TabletSCD26a52fdf-3992-c1c1-e063-6294a90a80f71
885213benztropine mesylate 1 MG Oral TabletSCD806ff51f-38be-4bf9-adc7-61efb11b5a6b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-2433-100060324331010 TABLET in 1 BOTTLE, PLASTIC (0603-2433-10) 10 tablet2022-03-170000-00-00NoNoCurrent
0603-2433-2100603243321100 TABLET in 1 BOTTLE, PLASTIC (0603-2433-21) 100 tablet2022-03-170000-00-00NoNoCurrent
0603-2433-32006032433321000 TABLET in 1 BOTTLE, PLASTIC (0603-2433-32) 1000 tablet2022-03-170000-00-00NoNoCurrent