Benztropine Mesylate

Product NDC: 0615-8222
11-digit product format: 006158222
Labeler code: 0615
Product ID: 0615-8222_c7b0eaab-bce7-4133-85e9-6ec282c63e7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benztropine mesylate
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
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: 2027-12-31
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-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 · 126 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
2026-08-18 06:07:40	2026-07	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040715-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040715-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040715-003	AA	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Benztropine Mesylate
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
df0647b8-2aa7-4aa4-9ba3-82c28698e7c5	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	Strength	SPL version
0615-8222-39	Benztropine Mesylate	30 in 1 BLISTER PACK	TABLET	30		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8222	BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	2	Current NDC, 1 package rows	20230615_df0647b8-2aa7-4aa4-9ba3-82c28698e7c5.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 ndc (product): 0615-8222
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

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0615-8222-39	00615822239	30 TABLET in 1 BLISTER PACK (0615-8222-39)	30 tablet	2023-06-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
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