benztropine mesylate

Product NDC: 67046-043
11-digit product format: 670460043
Labeler code: 67046
Product ID: 67046-043_8ab4fb43-045f-4104-bd62-55f8d3bae95a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benztropine mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA040103
Marketing category: ANDA
Marketing start: 2010-06-28
Marketing end: 0000-00-00
Substance: BENZTROPINE MESYLATE
Active strength: 2 mg/1
Pharmacologic classes: Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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	67046-043		I	Inactivated by FDA	2026-08-17
excluded package	package	67046-043	67046-043-30	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-043	67046-043-60	I	Inactivated by FDA	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 2 · 66 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	67046-043-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-043-30	`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	67046-043-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-043-30	`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	67046-043-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-043-30	`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	67046-043-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-043-30	`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	67046-043-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-043-30	`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	67046-043-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-043-30	`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	67046-043-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-043-30	`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	67046-043-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67046-043-30	`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	67046-043-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67046-043-30	`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	67046-043-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67046-043-30	`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	67046-043-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67046-043-30	`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	67046-043-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67046-043-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67046-043-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67046-043-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67046-043-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67046-043-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67046-043-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67046-043-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67046-043-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67046-043-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67046-043-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67046-043-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67046-043-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67046-043-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67046-043-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67046-043-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67046-043-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67046-043-30	`e2bbac7714bc…`	`27bdfed8d636…`

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
A040103-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12
A040103-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12
A040103-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040103-001	AA
A040103-002	AA
A040103-003	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	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL		1996-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL		1996-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL		1996-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL		1996-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL		1996-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL		1996-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL		1996-12-12	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040103-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040103-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040103-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040103-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040103-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040103-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040103-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040103-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040103-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040103-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040103-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040103-003	AA	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040103-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040103-002	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040103-003	AA	1	`a50c72e98297…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67046-043-30	2019-10-21	C162847	48780-1	956f9ecf-c59d-621f-e053-dbdaa90a74ad	BENZTROPINE MESYLATE TABLETS, USP
67046-043-60	2019-10-21	C162847	48780-1	956f9ecf-c59d-621f-e053-dbdaa90a74ad	BENZTROPINE MESYLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-043-30	benztropine mesylate	30 in 1 BLISTER PACK	TABLET	30		1
67046-043-60	benztropine mesylate	60 in 1 BLISTER PACK	TABLET	60		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
benztropine mesylate	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
benztropine	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-043	BENZTROPINE MESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 2 package rows	20100629_8ab4fb43-045f-4104-bd62-55f8d3bae95a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	513b1f4c-d253-6ad7-e063-6394a90a1dab	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040103 application number: ANDA040103
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	50c61b1d-49d6-37f2-e063-6294a90a0590	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040103 application number: ANDA040103
Benztropine Mesylate	BENZTROPINE MESYLATE	ScieGen Pharmaceuticals Inc	1ead16a7-88ed-407d-b25a-0d9a1d9da5ef	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040103 application number: ANDA040103

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
885213	benztropine mesylate 1 MG Oral Tablet	PSN	8ab4fb43-045f-4104-bd62-55f8d3bae95a	1
885209	benztropine mesylate 2 MG Oral Tablet	PSN	8ab4fb43-045f-4104-bd62-55f8d3bae95a	1
885213	benztropine mesylate 1 MG Oral Tablet	SCD	8ab4fb43-045f-4104-bd62-55f8d3bae95a	1
885209	benztropine mesylate 2 MG Oral Tablet	SCD	8ab4fb43-045f-4104-bd62-55f8d3bae95a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67046-043-30	67046004330	30 in 1 BLISTER PACK	Historical
67046-043-60	67046004360	60 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZTROPINE MESYLATE TABLETS, USP	Contract Pharmacy Services-PA	2010-06-28	HUMAN PRESCRIPTION DRUG LABEL	1