Benztropine Mesylate

Product NDC: 10135-607
11-digit product format: 101350607
Labeler code: 10135
Product ID: 10135-607_9548ae2a-05b0-4810-a8ca-4f22413712c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benztropine Mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA090168
Marketing category: ANDA
Marketing start: 2017-12-15
Marketing end: 0000-00-00
Substance: BENZTROPINE MESYLATE
Active strength: 1 mg/1
Pharmacologic classes: Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	10135-607		I	Inactivated by FDA	2026-08-17
excluded package	package	10135-607	10135-607-01	I	Inactivated by FDA	2026-08-17
excluded package	package	10135-607	10135-607-10	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 1 · 57 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	10135-607-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-607-10	`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	10135-607-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-607-10	`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	10135-607-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-607-10	`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	10135-607-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-607-10	`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	10135-607-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-607-10	`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	10135-607-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-607-10	`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	10135-607-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-607-10	`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	10135-607-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-607-10	`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	10135-607-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-607-10	`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	10135-607-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-607-10	`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	10135-607-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-607-10	`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	10135-607-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-607-10	`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	10135-607-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-607-10	`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	10135-607-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-607-10	`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	10135-607-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-607-10	`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	10135-607-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-607-10	`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	10135-607-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-607-10	`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	10135-607-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-607-10	`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	10135-607-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10135-607-10	`8dfbde2a14a4…`	`c9ff85d89658…`

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…`

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
10135-607-01	2021-01-29	C162847	48780-1	ba0f9c33-3b4c-a910-e053-dadaa90a0b85	Benztropine Mesylate
10135-607-10	2021-01-29	C162847	48780-1	ba0f9c33-3b4c-a910-e053-dadaa90a0b85	Benztropine Mesylate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-607-01	Benztropine Mesylate	100 in 1 BOTTLE, PLASTIC	TABLET	100		6
10135-607-10	Benztropine Mesylate	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-607-01	EA - Each	10135-607	b7c03d1e-597a-44cb-a972-b1b7194aee27	1	2016-03-04
10135-607-10	EA - Each	10135-607	9376b58b-929c-454b-b76e-6f4754212e58	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-607	BENZTROPINE MESYLATE TABLET [MARLEX PHARMACEUTICALS INC]	6	Legacy NDC, 2 package rows	20190518_e653f9bc-40db-4048-bcf2-6fa46db85895.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
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	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885213	benztropine mesylate 1 MG Oral Tablet	PSN	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885209	benztropine mesylate 2 MG Oral Tablet	PSN	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885213	benztropine mesylate 1 MG Oral Tablet	SCD	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885209	benztropine mesylate 2 MG Oral Tablet	SCD	e653f9bc-40db-4048-bcf2-6fa46db85895	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-607-01	10135060701	100 in 1 BOTTLE, PLASTIC	Historical
10135-607-10	10135060710	1000 in 1 BOTTLE, PLASTIC	Historical