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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	0603-2435	0603-2435-10	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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.

Product history page 1 of 4 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040715-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040715-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040715-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040715-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040715-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040715-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040715-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040715-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040715-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040715-001	AA	1	`8072bd15b7f6…`

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	2 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
0603-2435-10	Benztropine Mesylate	10 in 1 BOTTLE, PLASTIC	TABLET	10	9
0603-2435-21	Benztropine Mesylate	100 in 1 BOTTLE, PLASTIC	TABLET	100	9
0603-2435-32	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
0603-2435-21	EA - Each	0603-2435	40dc042e-d291-47b1-98f0-b56e5f15a9d3	1	2012-07-24
0603-2435-32	EA - Each	0603-2435	75e3bdc9-4124-4139-afa1-8970481b9758	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 [TYA PHARMACEUTICALS]	4
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]	4
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]	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
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [QUALITEST PHARMACEUTICALS]	4
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [DIRECT RX]	1
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [DIRECT RX]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-2435	BENZTROPINE MESYLATE TABLET [ENDO USA, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20241212_c19664aa-a797-4192-b5f3-e906a7cac048.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
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 (product): 0603-2435

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
885209	benztropine mesylate 2 MG Oral Tablet	PSN	959363b8-6847-4f6e-9957-6254febb085c	100
885209	benztropine mesylate 2 MG Oral Tablet	SCD	959363b8-6847-4f6e-9957-6254febb085c	100
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
885209	benztropine mesylate 2 MG Oral Tablet	PSN	bac9dfb7-aa09-4841-9e8f-cc41bb438fe2	10
885209	benztropine mesylate 2 MG Oral Tablet	SCD	bac9dfb7-aa09-4841-9e8f-cc41bb438fe2	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
885213	benztropine mesylate 1 MG Oral Tablet	PSN	c06c51ff-65ba-42c1-9dd8-e8d4a212981b	4
885209	benztropine mesylate 2 MG Oral Tablet	PSN	9b93035b-34d6-4084-ba73-5dea72f9d124	4
885209	benztropine mesylate 2 MG Oral Tablet	PSN	c06c51ff-65ba-42c1-9dd8-e8d4a212981b	4
885213	benztropine mesylate 1 MG Oral Tablet	SCD	c06c51ff-65ba-42c1-9dd8-e8d4a212981b	4
885209	benztropine mesylate 2 MG Oral Tablet	SCD	9b93035b-34d6-4084-ba73-5dea72f9d124	4
885209	benztropine mesylate 2 MG Oral Tablet	SCD	c06c51ff-65ba-42c1-9dd8-e8d4a212981b	4
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
885209	benztropine mesylate 2 MG Oral Tablet	PSN	d7698133-5cbc-4014-87a6-f2af23cbdff0	2
885209	benztropine mesylate 2 MG Oral Tablet	SCD	d7698133-5cbc-4014-87a6-f2af23cbdff0	2
885209	benztropine mesylate 2 MG Oral Tablet	PSN	52bd605a-6a28-c2ec-e063-6294a90a8371	1
885209	benztropine mesylate 2 MG Oral Tablet	SCD	52bd605a-6a28-c2ec-e063-6294a90a8371	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-2435-10	00603243510	10 TABLET in 1 BOTTLE, PLASTIC (0603-2435-10)	10 tablet	2022-03-17	0000-00-00	No	No	Current
0603-2435-21	00603243521	100 TABLET in 1 BOTTLE, PLASTIC (0603-2435-21)	100 tablet	2022-03-17	0000-00-00	No	No	Current
0603-2435-32	00603243532	1000 TABLET in 1 BOTTLE, PLASTIC (0603-2435-32)	1000 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	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	1
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	NCS HealthCare of KY, LLC dba Vangard Labs	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	10
BENZTROPINE MESYLATE	DIRECT RX	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	4
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	REMEDYREPACK INC.	2025-06-12	HUMAN PRESCRIPTION DRUG LABEL	7
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	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	101
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	Bryant Ranch Prepack	2023-05-30	HUMAN PRESCRIPTION DRUG LABEL	100
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	REMEDYREPACK INC.	2019-02-05	HUMAN PRESCRIPTION DRUG LABEL	3
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	State of Florida DOH Central Pharmacy	2014-03-07	HUMAN PRESCRIPTION DRUG LABEL	2
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	TYA Pharmaceuticals	2011-06-03	HUMAN PRESCRIPTION DRUG LABEL	4