benztropine mesylate

Product NDC
10858-011
11-digit product format
108580011
Labeler code
10858
Product ID
10858-011_67ef7746-45bc-466b-a7b7-353c8b8702c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Wintac Limited
Application
ANDA091525
Marketing category
ANDA
Marketing start
2020-11-26
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
1 mg/mL
Pharmacologic classes
Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10858-011IInactivated by FDA2026-08-17
excluded packagepackage10858-01110858-011-05IInactivated by FDA2026-08-17

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10858-011-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10858-011-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10858-011-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10858-011-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10858-011-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10858-011-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10858-011-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10858-011-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10858-011-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10858-011-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10858-011-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10858-011-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10858-011-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10858-011-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10858-011-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10858-011-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10858-011-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10858-011-05bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091525-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05

Therapeutic equivalence codes#

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

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

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-053f01610625f2…
2019-09-15 20:21 UTC2019-09A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091525-001BENZTROPINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2013-02-05e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091525-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091525-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091525-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091525-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091525-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091525-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091525-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091525-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091525-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091525-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091525-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091525-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091525-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091525-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091525-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091525-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091525-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091525-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091525-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091525-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091525-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091525-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A091525-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091525-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091525-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091525-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A091525-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091525-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091525-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091525-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091525-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091525-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091525-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091525-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091525-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091525-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091525-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091525-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091525-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091525-001AP1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2961cf47-535c-c402-c24d-0a9130269674Product name320251121
3f930a8b-cc65-fba9-e4ca-58b6abcea16bProduct name220220509

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10858-011-052022-01-28C16284748780-1d6a99b39-8070-a426-e053-dadaa90af4c2Benztropine mesylate injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10858-011-01benztropine mesylate2 mL in 1 VIALINJECTION21
10858-011-05benztropine mesylate5 in 1 CARTONINJECTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10858-011BENZTROPINE MESYLATE INJECTION [WINTAC LIMITED]1Legacy NDC, 2 package rows20201127_357140ce-d84f-43e2-a106-bb2175f46417.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATENavinta LLCf92fbafa-314d-4449-831f-26108339e6b22026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091525
application number: ANDA091525
Benztropine MesylateBENZTROPINE MESYLATEZydus Pharmaceuticals USA Inc.ecaeaadf-0847-4605-a205-a674f75f8bb22024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091525
application number: ANDA091525

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885205benztropine mesylate 2 MG in 2 ML InjectionPSN357140ce-d84f-43e2-a106-bb2175f464171
8852052 ML benztropine mesylate 1 MG/ML InjectionSCD357140ce-d84f-43e2-a106-bb2175f464171
885205benztropine mesylate 2 MG per 2 ML InjectionSY357140ce-d84f-43e2-a106-bb2175f464171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10858-011-01108580011012 mL in 1 VIAL2 mlHistorical
10858-011-05108580011055 VIAL in 1 CARTON (10858-011-05) > 2 mL in 1 VIAL (10858-011-01) 5 vial2020-11-260000-00-00NoNoCurrent