Home NDC 0615-2548 Benztropine Mesylate
Product NDC 0615-2548
11-digit product format 006152548
Labeler code 0615
Product ID 0615-2548_727070e9-1e14-4aab-b015-75abd66cd910
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benztropine Mesylate
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA089059
Marketing category ANDA
Marketing start 2010-02-28
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 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 1 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-2548-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-2548-31 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-2548-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-2548-31 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-2548-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-2548-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-2548-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-2548-31 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-2548-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-2548-31 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-2548-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-2548-31 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-2548-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-2548-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-2548-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-2548-31 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-2548-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-2548-31 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-2548-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-2548-31 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-2548-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-2548-31 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-2548-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-2548-31 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-2548-31 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-2548-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-2548-31 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-2548-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-2548-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-2548-31 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089059-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089059-001 AA
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089059-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1988-08-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZTROPINE MESYLATE ACTIVE INGREDIENT WMJ8TL7510 BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 BENZTROPINE ACTIVE MOIETY 1NHL2J4X8K BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6