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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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.
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 2026-08-01 22:54:32 2026-06 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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
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