Home NDC 11534-168-09 BENZTROPINE MESYLATE
Product NDC 11534-168
Requested package NDC 11534-168-09
11-digit product format 115340168
Labeler code 11534
Product ID 11534-168_192d20d2-c01e-4150-beb0-03f8da966acc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benztropine mesylate
Dosage form TABLET
Route ORAL
Labeler SUNRISE PHARMACEUTICAL, INC
Application ANDA204713
Marketing category ANDA
Marketing start 2024-10-16
Substance BENZTROPINE MESYLATE
Active strength 1 mg/1
Pharmacologic classes Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A204713-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 A204713-002 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 A204713-003 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14
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 · 129 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 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base BENZTROPINE MESYLATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZTROPINE MESYLATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WMJ8TL7510 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 885209 Internal RxNorm lookup 885213 Internal RxNorm lookup 885219 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11534-168-09 BENZTROPINE MESYLATE 100 in 1 BOTTLE TABLET 100 2 11534-168-10 BENZTROPINE MESYLATE 1000 in 1 BOTTLE TABLET 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11534-168 BENZTROPINE MESYLATE TABLET [SUNRISE PHARMACEUTICAL, INC] 2 Current NDC, 2 package rows 20241018_2c988462-ce77-4e99-b98e-8f6ad519e295.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 Sample Exclude flag Status 11534-168-09 11534016809 100 TABLET in 1 BOTTLE (11534-168-09) 100 tablet 2024-10-16 No No Current