Benztropine Mesylate

Product NDC: 0603-2433
Requested package NDC: 0603-2433-10
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0603-2433	0603-2433-10	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040715-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27
A040715-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27
A040715-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27

Therapeutic equivalence codes#

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

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

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A040715-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040715-002	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040715-003	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benztropine Mesylate	BENZTROPINE MESYLATE	Unit Dose Solutions, Inc.	53c02a89-012c-e724-e063-6294a90acc75	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	52bd605a-6a28-c2ec-e063-6294a90a8371	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	512ada3e-4b85-d989-e063-6394a90a9d54	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	5035534e-e15c-8f06-e063-6294a90a5003	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	bac9dfb7-aa09-4841-9e8f-cc41bb438fe2	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	DIRECT RX	9b93035b-34d6-4084-ba73-5dea72f9d124	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	df0647b8-2aa7-4aa4-9ba3-82c28698e7c5	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	American Health Packaging	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Major Pharmaceuticals	8b18b66c-2935-4304-8e20-ebf68dee5a1a	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	A-S Medication Solutions	53b134eb-b341-4fe4-a3ca-90a7da011974	2024-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Bryant Ranch Prepack	959363b8-6847-4f6e-9957-6254febb085c	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Endo USA, Inc.	c19664aa-a797-4192-b5f3-e906a7cac048	2022-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715 ndc (package): 0603-2433-10 ndc (product): 0603-2433 ndc11 (package): 00603243310

Additional Listing Data#

Finished product: Yes
Brand name base: Benztropine Mesylate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZTROPINE MESYLATE	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WMJ8TL7510	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c19664aa-a797-4192-b5f3-e906a7cac048	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2961cf47-535c-c402-c24d-0a9130269674	Product name	3	20251121
3f930a8b-cc65-fba9-e4ca-58b6abcea16b	Product name	2	20220509

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0603-2433-10	Benztropine Mesylate	10 in 1 BOTTLE, PLASTIC	TABLET	10	9
0603-2433-21	Benztropine Mesylate	100 in 1 BOTTLE, PLASTIC	TABLET	100	9
0603-2433-32	Benztropine Mesylate	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-2433-21	EA - Each	0603-2433	ed194a4f-8cbb-421b-ba46-6d8a3322f7f3	1	2012-07-24
0603-2433-32	EA - Each	0603-2433	d2e9a1f6-a912-4d95-a0a0-3d114793e373	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-2433	BENZTROPINE MESYLATE TABLET [ENDO USA, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20241212_c19664aa-a797-4192-b5f3-e906a7cac048.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WMJ8TL7510	BENZTROPINE MESYLATE	132-17-2	BENZTROPINE MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	13
885213	benztropine mesylate 1 MG Oral Tablet	PSN	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	13
885209	benztropine mesylate 2 MG Oral Tablet	PSN	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	13
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	13
885213	benztropine mesylate 1 MG Oral Tablet	SCD	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	13
885209	benztropine mesylate 2 MG Oral Tablet	SCD	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	13
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	df0647b8-2aa7-4aa4-9ba3-82c28698e7c5	10
885213	benztropine mesylate 1 MG Oral Tablet	PSN	df0647b8-2aa7-4aa4-9ba3-82c28698e7c5	10
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	df0647b8-2aa7-4aa4-9ba3-82c28698e7c5	10
885213	benztropine mesylate 1 MG Oral Tablet	SCD	df0647b8-2aa7-4aa4-9ba3-82c28698e7c5	10
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	c19664aa-a797-4192-b5f3-e906a7cac048	9
885213	benztropine mesylate 1 MG Oral Tablet	PSN	c19664aa-a797-4192-b5f3-e906a7cac048	9
885209	benztropine mesylate 2 MG Oral Tablet	PSN	c19664aa-a797-4192-b5f3-e906a7cac048	9
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	c19664aa-a797-4192-b5f3-e906a7cac048	9
885213	benztropine mesylate 1 MG Oral Tablet	SCD	c19664aa-a797-4192-b5f3-e906a7cac048	9
885209	benztropine mesylate 2 MG Oral Tablet	SCD	c19664aa-a797-4192-b5f3-e906a7cac048	9
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	8b18b66c-2935-4304-8e20-ebf68dee5a1a	3
885213	benztropine mesylate 1 MG Oral Tablet	PSN	8b18b66c-2935-4304-8e20-ebf68dee5a1a	3
885209	benztropine mesylate 2 MG Oral Tablet	PSN	8b18b66c-2935-4304-8e20-ebf68dee5a1a	3
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	8b18b66c-2935-4304-8e20-ebf68dee5a1a	3
885213	benztropine mesylate 1 MG Oral Tablet	SCD	8b18b66c-2935-4304-8e20-ebf68dee5a1a	3
885209	benztropine mesylate 2 MG Oral Tablet	SCD	8b18b66c-2935-4304-8e20-ebf68dee5a1a	3
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	512ada3e-4b85-d989-e063-6394a90a9d54	1
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	26a52fdf-3992-c1c1-e063-6294a90a80f7	1
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	806ff51f-38be-4bf9-adc7-61efb11b5a6b	1
885213	benztropine mesylate 1 MG Oral Tablet	PSN	806ff51f-38be-4bf9-adc7-61efb11b5a6b	1
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	806ff51f-38be-4bf9-adc7-61efb11b5a6b	1
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	512ada3e-4b85-d989-e063-6394a90a9d54	1
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	26a52fdf-3992-c1c1-e063-6294a90a80f7	1
885213	benztropine mesylate 1 MG Oral Tablet	SCD	806ff51f-38be-4bf9-adc7-61efb11b5a6b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-2433-10	00603243310	10 TABLET in 1 BOTTLE, PLASTIC (0603-2433-10)	10 tablet	2022-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	Coupler LLC	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	1
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg	NCS HealthCare of KY, LLC dba Vangard Labs	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	10
Benztropine Mesylate Tablets, USP 8238101/1025 Rx only	American Health Packaging	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	13
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	Major Pharmaceuticals	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	3
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	Coupler LLC	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	Correct Rx Pharmacy Services, Inc.	2024-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	Endo USA, Inc.	2022-03-16	HUMAN PRESCRIPTION DRUG LABEL	9
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	Aphena Pharma Solutions - Tennessee, LLC	2014-05-21	HUMAN PRESCRIPTION DRUG LABEL	1