Benztropine Mesylate

Product NDC: 69097-826
11-digit product format: 690970826
Labeler code: 69097
Product ID: 69097-826_3d362141-de53-4949-b9a5-34f2b7bb0e75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benztropine
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA090294
Marketing category: ANDA
Marketing start: 2016-06-29
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	Approval date
A090294-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29
A090294-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29
A090294-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090294-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090294-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090294-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090294-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090294-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090294-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090294-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090294-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090294-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090294-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090294-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090294-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090294-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090294-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090294-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090294-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090294-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090294-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090294-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090294-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090294-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090294-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090294-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090294-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090294-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090294-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090294-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090294-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090294-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090294-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090294-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090294-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090294-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090294-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090294-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090294-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090294-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090294-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090294-003	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090294-001	AA	1	`6a51e52b5d6a…`

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
3d2732f9-b8a9-4e83-91e7-da616ddcb786	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
69097-826-02	Benztropine Mesylate	30 in 1 BOTTLE	TABLET	30	3
69097-826-07	Benztropine Mesylate	100 in 1 BOTTLE	TABLET	100	3
69097-826-15	Benztropine Mesylate	1000 in 1 BOTTLE	TABLET	1000	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-826-07	EA - Each	69097-826	998cfed6-4ca7-4df6-a587-3e8c51c7af56	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-826	BENZTROPINE MESYLATE (BENZTROPINE) TABLET [CIPLA USA INC.]	3	Current NDC, Legacy NDC, 3 package rows	20200502_3d2732f9-b8a9-4e83-91e7-da616ddcb786.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benztropine Mesylate	BENZTROPINE	Cipla USA Inc.	3d2732f9-b8a9-4e83-91e7-da616ddcb786	2020-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090294 application number: ANDA090294 ndc (product): 69097-826

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WMJ8TL7510	BENZTROPINE MESYLATE	132-17-2	BENZTROPINE MESYLATE
1NHL2J4X8K	BENZTROPINE	86-13-5	Benztropine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	3d2732f9-b8a9-4e83-91e7-da616ddcb786	3
885213	benztropine mesylate 1 MG Oral Tablet	PSN	3d2732f9-b8a9-4e83-91e7-da616ddcb786	3
885209	benztropine mesylate 2 MG Oral Tablet	PSN	3d2732f9-b8a9-4e83-91e7-da616ddcb786	3
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	3d2732f9-b8a9-4e83-91e7-da616ddcb786	3
885213	benztropine mesylate 1 MG Oral Tablet	SCD	3d2732f9-b8a9-4e83-91e7-da616ddcb786	3
885209	benztropine mesylate 2 MG Oral Tablet	SCD	3d2732f9-b8a9-4e83-91e7-da616ddcb786	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-826-02	69097082602	30 TABLET in 1 BOTTLE (69097-826-02)	30 tablet	2016-06-29	0000-00-00	No	No	Current
69097-826-07	69097082607	100 TABLET in 1 BOTTLE (69097-826-07)	100 tablet	2016-06-29	0000-00-00	No	No	Current
69097-826-15	69097082615	1000 TABLET in 1 BOTTLE (69097-826-15)	1000 tablet	2016-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benztropine Mesylate Tablets, USP	Cipla USA Inc. \| InvaGen Pharmaceutical Inc	2020-05-01	HUMAN PRESCRIPTION DRUG LABEL	3