BENZTROPINE MESYLATE

Product NDC: 70752-125
Requested package NDC: 70752-125-10
11-digit product format: 707520125
Labeler code: 70752
Product ID: 70752-125_073409b4-0ae6-43d5-804a-a15ca581ecd9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZTROPINE MESYLATE
Dosage form: TABLET
Route: ORAL
Labeler: QUAGEN PHARMACEUTICALS LLC
Application: ANDA212694
Marketing category: ANDA
Marketing start: 2025-08-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212694-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11
A212694-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11
A212694-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212694-001	AA
A212694-002	AA
A212694-003	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
2026-09-14 22:38:34	2026-08	A212694-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212694-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212694-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212694-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212694-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212694-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212694-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212694-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212694-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212694-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212694-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212694-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212694-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212694-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212694-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212694-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212694-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212694-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212694-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212694-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212694-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212694-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2025-02-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212694-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2025-02-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212694-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2025-02-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212694-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212694-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212694-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212694-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212694-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212694-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212694-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212694-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212694-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212694-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212694-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212694-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212694-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212694-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212694-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212694-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212694-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212694-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212694-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212694-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212694-003	AA	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212694-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212694-002	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212694-003	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
e1f0a249-e660-4592-9ffc-1c02b1022778	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
70752-125-10	BENZTROPINE MESYLATE	100 in 1 BOTTLE, PLASTIC	TABLET	100		4
70752-125-11	BENZTROPINE MESYLATE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70752-125-10	EA - Each	70752-125	3d09422c-abf6-42c9-87b3-72a857f6326c	1	2025-08-11
70752-125-11	EA - Each	70752-125	591e10ac-b8fd-4db1-9b50-566861cfb8d7	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70752-125	BENZTROPINE MESYLATE TABLET [QUAGEN PHARMACEUTICALS LLC]	3	Current NDC, 2 package rows	20250322_e1f0a249-e660-4592-9ffc-1c02b1022778.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Bryant Ranch Prepack	ae749a71-d253-474d-a26c-bec780c5b09c	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212694 application number: ANDA212694
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Bryant Ranch Prepack	9270d14c-b885-4679-8871-6f2547450398	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212694 application number: ANDA212694
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Bryant Ranch Prepack	284e78af-7544-4c4a-8081-74e45501dc76	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212694 application number: ANDA212694
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	QUAGEN PHARMACEUTICALS LLC	e1f0a249-e660-4592-9ffc-1c02b1022778	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212694 application number: ANDA212694 ndc (package): 70752-125-10 ndc (product): 70752-125 ndc11 (package): 70752012510

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	284e78af-7544-4c4a-8081-74e45501dc76	100
885209	benztropine mesylate 2 MG Oral Tablet	SCD	284e78af-7544-4c4a-8081-74e45501dc76	100
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	e1f0a249-e660-4592-9ffc-1c02b1022778	4
885213	benztropine mesylate 1 MG Oral Tablet	PSN	e1f0a249-e660-4592-9ffc-1c02b1022778	4
885209	benztropine mesylate 2 MG Oral Tablet	PSN	e1f0a249-e660-4592-9ffc-1c02b1022778	4
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	e1f0a249-e660-4592-9ffc-1c02b1022778	4
885213	benztropine mesylate 1 MG Oral Tablet	SCD	e1f0a249-e660-4592-9ffc-1c02b1022778	4
885209	benztropine mesylate 2 MG Oral Tablet	SCD	e1f0a249-e660-4592-9ffc-1c02b1022778	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70752-125-10	70752012510	100 TABLET in 1 BOTTLE, PLASTIC (70752-125-10)	100 tablet	2025-08-11	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 Rx only	Bryant Ranch Prepack	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	100
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only	QUAGEN PHARMACEUTICALS LLC	2025-06-17	HUMAN PRESCRIPTION DRUG LABEL	4