Benztropine Mesylate

Product NDC
68084-389
11-digit product format
680840389
Labeler code
68084
Product ID
68084-389_43e32855-d7c9-07e1-e063-6294a90af347
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040715
Marketing category
ANDA
Marketing start
2013-07-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040715-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27
A040715-002BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27
A040715-003BENZTROPINE MESYLATEBENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040715-001AA
A040715-002AA
A040715-003AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-271e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040715-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040715-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040715-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040715-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040715-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040715-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040715-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040715-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040715-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040715-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040715-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040715-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040715-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040715-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040715-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040715-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040715-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040715-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040715-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040715-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040715-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040715-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040715-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040715-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040715-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040715-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040715-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040715-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040715-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040715-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040715-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040715-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040715-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040715-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040715-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040715-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040715-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040715-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040715-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040715-001AA11e350fbaab3a…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WMJ8TL7510Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
885209Internal RxNorm lookup
885213Internal RxNorm lookup
885219Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b7f915a9-cd53-4a74-8ee5-35ee5c5c991eAvailable on FDA.report

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
68084-389-01Benztropine Mesylate100 in 1 BOX, UNIT-DOSETABLET10013
68084-389-11Benztropine Mesylate1 in 1 BLISTER PACKTABLET113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-389-01EA - Each68084-3896a7b23c6-09d6-4569-bc89-522f4d53dbe412012-07-24
68084-389-11EA - Each68084-38971d18107-c377-4314-9c18-b0017a47110112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-389BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 2 package rows20241215_b7f915a9-cd53-4a74-8ee5-35ee5c5c991e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATEUnit Dose Solutions, Inc.53c02a89-012c-e724-e063-6294a90acc752026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC52bd605a-6a28-c2ec-e063-6294a90a83712026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC512ada3e-4b85-d989-e063-6394a90a9d542026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC5035534e-e15c-8f06-e063-6294a90a50032026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsbac9dfb7-aa09-4841-9e8f-cc41bb438fe22026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
BENZTROPINE MESYLATEBENZTROPINE MESYLATEDIRECT RX9b93035b-34d6-4084-ba73-5dea72f9d1242026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsdf0647b8-2aa7-4aa4-9ba3-82c28698e7c52026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATEAmerican Health Packagingb7f915a9-cd53-4a74-8ee5-35ee5c5c991e2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
ndc (product): 68084-389
Benztropine MesylateBENZTROPINE MESYLATEMajor Pharmaceuticals8b18b66c-2935-4304-8e20-ebf68dee5a1a2025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATEA-S Medication Solutions53b134eb-b341-4fe4-a3ca-90a7da0119742024-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATEBryant Ranch Prepack959363b8-6847-4f6e-9957-6254febb085c2023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATEEndo USA, Inc.c19664aa-a797-4192-b5f3-e906a7cac0482022-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-389-0168084038901100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-389-01) / 1 TABLET in 1 BLISTER PACK (68084-389-11) 100 blister pack2013-07-010000-00-00NoNoCurrent
68084-389-11680840389111 in 1 BLISTER PACKHistorical