Home NDC 0603-2437-21 Benztropine Mesylate
Product NDC 0603-2437
Requested package NDC 0603-2437-21
11-digit product format 006032437
Labeler code 0603
Product ID 0603-2437_7d977221-80bc-44cc-8210-c69e9bd3e368
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benztropine mesylate
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA204713
Marketing category ANDA
Marketing start 2017-05-15
Marketing end 0000-00-00
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 2024-12-31
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 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 · 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0603-2437-21 00603243721 100 TABLET in 1 BOTTLE, PLASTIC (0603-2437-21) 100 tablet 2017-05-15 0000-00-00 No No Current