FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
0603-2435
11-digit product format
006032435
Labeler code
0603
Product ID
0603-2435_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
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
0603-2435-10Benztropine Mesylate10 in 1 BOTTLE, PLASTICTABLET109
0603-2435-21Benztropine Mesylate100 in 1 BOTTLE, PLASTICTABLET1009
0603-2435-32Benztropine Mesylate1000 in 1 BOTTLE, PLASTICTABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-2435-21EA - Each0603-243540dc042e-d291-47b1-98f0-b56e5f15a9d312012-07-24
0603-2435-32EA - Each0603-243575e3bdc9-4124-4139-afa1-8970481b975812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]4
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]4
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]4
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [DIRECT RX]1
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [DIRECT RX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JBENZTROPINE MESYLATE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-2435BENZTROPINE 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
885209benztropine mesylate 2 MG Oral TabletPSN959363b8-6847-4f6e-9957-6254febb085c100
885209benztropine mesylate 2 MG Oral TabletSCD959363b8-6847-4f6e-9957-6254febb085c100
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
885209benztropine mesylate 2 MG Oral TabletPSNbac9dfb7-aa09-4841-9e8f-cc41bb438fe210
885209benztropine mesylate 2 MG Oral TabletSCDbac9dfb7-aa09-4841-9e8f-cc41bb438fe210
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
885213benztropine mesylate 1 MG Oral TabletPSNc06c51ff-65ba-42c1-9dd8-e8d4a212981b4
885209benztropine mesylate 2 MG Oral TabletPSN9b93035b-34d6-4084-ba73-5dea72f9d1244
885209benztropine mesylate 2 MG Oral TabletPSNc06c51ff-65ba-42c1-9dd8-e8d4a212981b4
885213benztropine mesylate 1 MG Oral TabletSCDc06c51ff-65ba-42c1-9dd8-e8d4a212981b4
885209benztropine mesylate 2 MG Oral TabletSCD9b93035b-34d6-4084-ba73-5dea72f9d1244
885209benztropine mesylate 2 MG Oral TabletSCDc06c51ff-65ba-42c1-9dd8-e8d4a212981b4
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
885209benztropine mesylate 2 MG Oral TabletPSNd7698133-5cbc-4014-87a6-f2af23cbdff02
885209benztropine mesylate 2 MG Oral TabletSCDd7698133-5cbc-4014-87a6-f2af23cbdff02
885209benztropine mesylate 2 MG Oral TabletPSN52bd605a-6a28-c2ec-e063-6294a90a83711
885209benztropine mesylate 2 MG Oral TabletSCD52bd605a-6a28-c2ec-e063-6294a90a83711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-2435-100060324351010 TABLET in 1 BOTTLE, PLASTIC (0603-2435-10) 10 tablet2022-03-170000-00-00NoNoCurrent
0603-2435-2100603243521100 TABLET in 1 BOTTLE, PLASTIC (0603-2435-21) 100 tablet2022-03-170000-00-00NoNoCurrent
0603-2435-32006032435321000 TABLET in 1 BOTTLE, PLASTIC (0603-2435-32) 1000 tablet2022-03-170000-00-00NoNoCurrent