Home NDC 10858-011-05 benztropine mesylate
Product NDC 10858-011
Requested package NDC 10858-011-05
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 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 RLD / RS 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10858-011-05 10858001105 5 VIAL in 1 CARTON (10858-011-05) > 2 mL in 1 VIAL (10858-011-01) 5 vial 2020-11-26 0000-00-00 No No Current