Home NDC 0832-1082-10 Benztropine Mesylate
Product NDC 0832-1082
Requested package NDC 0832-1082-10
11-digit product format 008321082
Labeler code 0832
Product ID 0832-1082_2711e70f-cc34-4092-b4fc-47e426cef420
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benztropine mesylate
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA040103
Marketing category ANDA
Marketing start 1996-12-12
Marketing end 0000-00-00
Substance BENZTROPINE MESYLATE
Active strength 2 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 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 · 12 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…
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 RLD / RS Approval date A040103-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 A040103-002 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 A040103-003 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 1996-12-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 1996-12-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 1996-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 1996-12-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 1996-12-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 1996-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 1996-12-12 1e350fbaab3a…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZTROPINE MESYLATE ACTIVE INGREDIENT WMJ8TL7510 BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 BENZTROPINE ACTIVE MOIETY 1NHL2J4X8K BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 benztropine mesylate ACTIVE INGREDIENT WMJ8TL7510 BENZTROPINE MESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.] 3 benztropine ACTIVE MOIETY 1NHL2J4X8K BENZTROPINE MESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.] 3 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK BENZTROPINE MESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 BENZTROPINE MESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BENZTROPINE MESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.] 3 povidones INACTIVE INGREDIENT FZ989GH94E BENZTROPINE MESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.] 3 BENZTROPINE MESYLATE ACTIVE INGREDIENT WMJ8TL7510 BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 benztropine mesylate ACTIVE INGREDIENT WMJ8TL7510 BENZTROPINE MESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 benztropine ACTIVE MOIETY 1NHL2J4X8K BENZTROPINE MESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 BENZTROPINE ACTIVE MOIETY 1NHL2J4X8K BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
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 · 3 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 0832-1082-10 00832108210 1000 TABLET in 1 BOTTLE (0832-1082-10) 1000 tablet 1996-12-12 0000-00-00 No No Current