Home NDC 67046-043 benztropine mesylate
Product NDC 67046-043
11-digit product format 670460043
Labeler code 67046
Product ID 67046-043_8ab4fb43-045f-4104-bd62-55f8d3bae95a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benztropine mesylate
Dosage form TABLET
Route ORAL
Labeler Contract Pharmacy Services-PA
Application ANDA040103
Marketing category ANDA
Marketing start 2010-06-28
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 E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 132 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 2026-10-15 13:18:30 2026-09 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040103-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 1996-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040103-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1996-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040103-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1996-12-12 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A040103-002 AA 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A040103-003 AA 1 a50c72e98297…
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 67046-043-30 benztropine mesylate 30 in 1 BLISTER PACK TABLET 30 1 67046-043-60 benztropine mesylate 60 in 1 BLISTER PACK TABLET 60 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-043 BENZTROPINE MESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 Legacy NDC, 2 package rows 20100629_8ab4fb43-045f-4104-bd62-55f8d3bae95a.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 67046-043-30 67046004330 30 in 1 BLISTER PACK Historical 67046-043-60 67046004360 60 in 1 BLISTER PACK Historical