Benztropine Mesylate

Product NDC: 43353-913
11-digit product format: 433530913
Labeler code: 43353
Product ID: 43353-913_f64c95f3-04d8-4fae-98eb-7c794c449480
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benztropine mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA040738
Marketing category: ANDA
Marketing start: 2007-08-27
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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43353-913		I	Inactivated by FDA		2026-08-17
excluded package	package	43353-913	43353-913-09	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 · 42 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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`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	43353-913-09	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-913-09	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog.

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
43353-913-09	2020-01-31	C162847	48780-1	9d75b9d0-7bf7-f424-e053-dadaa90a57ce	BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-913-09	Benztropine Mesylate	9000 in 1 BOTTLE, PLASTIC	TABLET	9000		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-913	BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20140521_806ff51f-38be-4bf9-adc7-61efb11b5a6b.zip

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	806ff51f-38be-4bf9-adc7-61efb11b5a6b	1
885213	benztropine mesylate 1 MG Oral Tablet	PSN	806ff51f-38be-4bf9-adc7-61efb11b5a6b	1
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	806ff51f-38be-4bf9-adc7-61efb11b5a6b	1
885213	benztropine mesylate 1 MG Oral Tablet	SCD	806ff51f-38be-4bf9-adc7-61efb11b5a6b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-913-09	43353091309	9000 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	Aphena Pharma Solutions - Tennessee, LLC	2014-05-21	HUMAN PRESCRIPTION DRUG LABEL	1