BENZTROPINE MESYLATE

Product NDC: 11534-169
11-digit product format: 115340169
Labeler code: 11534
Product ID: 11534-169_192d20d2-c01e-4150-beb0-03f8da966acc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benztropine mesylate
Dosage form: TABLET
Route: ORAL
Labeler: SUNRISE PHARMACEUTICAL, INC
Application: ANDA204713
Marketing category: ANDA
Marketing start: 2024-10-16
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11534-169		D	Discontinued by firm	2026-08-17
excluded package	package	11534-169	11534-169-01	D	Discontinued by firm	2026-08-17
excluded package	package	11534-169	11534-169-03	D	Discontinued by firm	2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11534-169-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11534-169-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11534-169-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11534-169-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11534-169-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11534-169-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11534-169-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11534-169-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11534-169-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11534-169-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11534-169-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11534-169-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11534-169-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11534-169-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11534-169-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11534-169-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11534-169-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11534-169-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11534-169-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11534-169-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11534-169-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11534-169-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11534-169-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11534-169-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
A204713-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14
A204713-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14
A204713-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204713-001	AA
A204713-002	AA
A204713-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204713-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	RS	2015-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204713-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	RS	2015-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204713-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	RS	2015-04-14	`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	A204713-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204713-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204713-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204713-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204713-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204713-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204713-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204713-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204713-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204713-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204713-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204713-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204713-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204713-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204713-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204713-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204713-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204713-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204713-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204713-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204713-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204713-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204713-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204713-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204713-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204713-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204713-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204713-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204713-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204713-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204713-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204713-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204713-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204713-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204713-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204713-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204713-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204713-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204713-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204713-001	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	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
2c988462-ce77-4e99-b98e-8f6ad519e295	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
11534-169-09	BENZTROPINE MESYLATE	100 in 1 BOTTLE	TABLET	100		2
11534-169-10	BENZTROPINE MESYLATE	1000 in 1 BOTTLE	TABLET	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11534-169-01	EA - Each	11534-169	c8039670-a122-4250-93d9-685a766e57c8	1	2015-10-02
11534-169-03	EA - Each	11534-169	dc5deedc-9864-45a8-9bde-4c4ed00d2759	1	2015-10-02
11534-169-09	EA - Each	11534-169	8688c2be-4a5b-498d-a84c-0daa8355da32	1	2024-12-10
11534-169-10	EA - Each	11534-169	e59ef381-684b-4b55-b423-e04047d114e7	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11534-169	BENZTROPINE MESYLATE TABLET [SUNRISE PHARMACEUTICAL, INC]	2	Current NDC, 2 package rows	20241018_2c988462-ce77-4e99-b98e-8f6ad519e295.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Marlex PHARMACEUTICAL, INC	31bbcbfa-dc74-99e2-e063-6394a90aa608	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204713 application number: ANDA204713
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	SUNRISE PHARMACEUTICAL, INC	2c988462-ce77-4e99-b98e-8f6ad519e295	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204713 application number: ANDA204713 ndc (product): 11534-169

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	2c988462-ce77-4e99-b98e-8f6ad519e295	2
885213	benztropine mesylate 1 MG Oral Tablet	PSN	2c988462-ce77-4e99-b98e-8f6ad519e295	2
885209	benztropine mesylate 2 MG Oral Tablet	PSN	2c988462-ce77-4e99-b98e-8f6ad519e295	2
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	2c988462-ce77-4e99-b98e-8f6ad519e295	2
885213	benztropine mesylate 1 MG Oral Tablet	SCD	2c988462-ce77-4e99-b98e-8f6ad519e295	2
885209	benztropine mesylate 2 MG Oral Tablet	SCD	2c988462-ce77-4e99-b98e-8f6ad519e295	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
11534-169-09	11534016909	100 TABLET in 1 BOTTLE (11534-169-09)	100 tablet	2024-10-16	No	No	Current
11534-169-10	11534016910	1000 TABLET in 1 BOTTLE (11534-169-10)	1000 tablet	2024-10-16	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	SUNRISE PHARMACEUTICAL, INC \| SUNRISE PHARMACEUTICAL INC.	2024-10-16	HUMAN PRESCRIPTION DRUG LABEL	2