BENZTROPINE MESYLATE

Product NDC: 69315-136
11-digit product format: 693150136
Labeler code: 69315
Product ID: 69315-136_f61e0118-7898-42cf-9e27-e5f2dabe6ea4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZTROPINE MESYLATE
Dosage form: TABLET
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA090168
Marketing category: ANDA
Marketing start: 2012-11-28
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

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
A090168-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28
A090168-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28
A090168-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090168-001	AA
A090168-002	AA
A090168-003	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	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`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	A090168-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090168-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090168-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090168-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090168-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090168-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090168-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090168-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090168-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090168-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090168-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090168-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090168-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090168-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090168-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090168-001	AA	1	`1e350fbaab3a…`

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
fe002ec4-07cb-41ca-a58c-33b3a8682101	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
69315-136-01	BENZTROPINE MESYLATE	100 in 1 BOTTLE	TABLET	100		8
69315-136-10	BENZTROPINE MESYLATE	1000 in 1 BOTTLE	TABLET	1000		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-136-01	EA - Each	69315-136	035b4c84-17e4-48a5-8d39-49ece51cd718	1	2016-06-14
69315-136-10	EA - Each	69315-136	588b637e-a3c4-472f-ba93-ae676a919712	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-136	BENZTROPINE MESYLATE TABLET [LEADING PHARMA, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20211123_fe002ec4-07cb-41ca-a58c-33b3a8682101.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	241479dd-91bf-455a-80a1-1bb2d1c8156d	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	01688e6f-7b22-41bf-9a85-1c88d90f99b6	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	7430b584-2812-4af5-994a-33dd1afed476	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Leading Pharma, LLC	fe002ec4-07cb-41ca-a58c-33b3a8682101	2021-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168 ndc (product): 69315-136
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	f82c6455-f36b-49d7-881e-6601d513d846	2021-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Proficient Rx LP	c1044563-2bd2-4f43-a951-25d083b1c679	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168

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	241479dd-91bf-455a-80a1-1bb2d1c8156d	14
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	241479dd-91bf-455a-80a1-1bb2d1c8156d	14
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	fe002ec4-07cb-41ca-a58c-33b3a8682101	8
885213	benztropine mesylate 1 MG Oral Tablet	PSN	fe002ec4-07cb-41ca-a58c-33b3a8682101	8
885209	benztropine mesylate 2 MG Oral Tablet	PSN	fe002ec4-07cb-41ca-a58c-33b3a8682101	8
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	fe002ec4-07cb-41ca-a58c-33b3a8682101	8
885213	benztropine mesylate 1 MG Oral Tablet	SCD	fe002ec4-07cb-41ca-a58c-33b3a8682101	8
885209	benztropine mesylate 2 MG Oral Tablet	SCD	fe002ec4-07cb-41ca-a58c-33b3a8682101	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69315-136-01	69315013601	100 TABLET in 1 BOTTLE (69315-136-01)	100 tablet	2016-05-15	0000-00-00	No	No	Current
69315-136-10	69315013610	1000 TABLET in 1 BOTTLE (69315-136-10)	1000 tablet	2016-05-15	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	REMEDYREPACK INC.	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	15
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg	Leading Pharma, LLC	2021-11-14	HUMAN PRESCRIPTION DRUG LABEL	8
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg	NCS HealthCare of KY, Inc dba Vangard Labs	2017-10-12	HUMAN PRESCRIPTION DRUG LABEL	4