Benztropine mesylate injection, USP

Manufacturer: Wintac Limited | Navinta LLC
Effective date: 2020-11-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:34:01

Label at a glance#

Productbenztropine mesylate

Active ingredientBENZTROPINE MESYLATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC-10858-011-01

Benztropine Mesylate

Injection, USP

2 mg/2 mL (1 mg/mL)

For Intravenous or Intramuscular use

2 mL Single Dose Vial

Wintac Limited

Rx only

NDC 10858-011-05

Benztropine Mesylate

Injection, USP

2 mg/2 mL (1 mg/mL)

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Wintac Limited

5 X 2 mL Single Dose Vials

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
885205	benztropine mesylate 2 MG in 2 ML Injection	PSN	1
885205	2 ML benztropine mesylate 1 MG/ML Injection	SCD	1
885205	benztropine mesylate 2 MG per 2 ML Injection	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZTROPINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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
10858-011-05	2022-01-28	C162847	48780-1	d6a99b39-8070-a426-e053-dadaa90af4c2	Benztropine mesylate injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10858-011-01	benztropine mesylate	2 mL in 1 VIAL	INJECTION	2		1
10858-011-05	benztropine mesylate	5 in 1 CARTON	INJECTION	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10858-011	BENZTROPINE MESYLATE INJECTION [WINTAC LIMITED]	1	Legacy NDC, 2 package rows	20201127_357140ce-d84f-43e2-a106-bb2175f46417.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

benztropine mesylate
BENZTROPINE
SODIUM CHLORIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10858-011	10858-011-01, 10858-011-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZTROPINE MESYLATE	WMJ8TL7510	ACTIB
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091525-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP		2013-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091525-001	AP

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 2 · 43 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
2026-09-14 22:38:34	2026-08	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091525-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091525-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091525-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091525-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091525-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091525-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091525-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091525-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091525-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091525-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091525-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091525-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091525-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091525-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091525-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091525-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091525-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091525-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091525-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091525-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091525-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091525-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091525-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091525-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091525-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091525-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091525-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091525-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091525-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091525-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091525-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091525-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091525-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091525-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091525-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091525-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091525-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091525-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091525-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091525-001	AP	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
67ef7746-45bc-466b-a7b7-353c8b8702c1			357140ce-d84f-43e2-a106-bb2175f46417	2020-11-26		Exact identifier spl id: 67ef7746-45bc-466b-a7b7-353c8b8702c1 spl set id: 357140ce-d84f-43e2-a106-bb2175f46417

Reported adverse events (FAERS/openFDA)#

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