Home NDC 31722-219 Benztropine Mesylate
Product NDC 31722-219
11-digit product format 317220219
Labeler code 31722
Product ID 31722-219_c91afeb7-1f26-4fdc-b1d2-4a11f2e6a88b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benztropine mesylate
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceutical, Inc.
Application ANDA090294
Marketing category ANDA
Marketing start 2013-08-01
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 2 · 88 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 31722-219-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 31722-219-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 31722-219-30 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 31722-219-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 31722-219-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 31722-219-30 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 31722-219-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 31722-219-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 31722-219-30 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 31722-219-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 31722-219-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 31722-219-30 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 31722-219-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 31722-219-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 31722-219-30 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 31722-219-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 31722-219-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 31722-219-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 31722-219-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 31722-219-10 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 31722-219-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 31722-219-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 31722-219-10 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 31722-219-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 31722-219-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 31722-219-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 31722-219-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 31722-219-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 31722-219-10 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 31722-219-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 31722-219-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 31722-219-10 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 31722-219-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 31722-219-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 31722-219-10 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 31722-219-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 31722-219-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 31722-219-10 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 31722-219-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 31722-219-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 31722-219-10 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 31722-219-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 31722-219-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 31722-219-10 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 31722-219-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 A090294-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 A090294-002 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 A090294-003 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29
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 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090294-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL 2010-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090294-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL 2010-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090294-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL 2010-03-29 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 31722-219-01 2025-02-19 BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg 31722-219-10 2025-02-19 BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg 31722-219-30 2025-02-19 BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg 31722-219-01 2019-11-27 BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg 31722-219-10 2019-11-27 BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg 31722-219-30 2019-11-27 BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZTROPINE MESYLATE ACTIVE INGREDIENT WMJ8TL7510 BENZTROPINE MESYLATE TABLET [CAMBER PHARMACEUTICAL, INC.] 1 BENZTROPINE ACTIVE MOIETY 1NHL2J4X8K BENZTROPINE MESYLATE TABLET [CAMBER PHARMACEUTICAL, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BENZTROPINE MESYLATE TABLET [CAMBER PHARMACEUTICAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BENZTROPINE MESYLATE TABLET [CAMBER PHARMACEUTICAL, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BENZTROPINE MESYLATE TABLET [CAMBER PHARMACEUTICAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BENZTROPINE MESYLATE TABLET [CAMBER PHARMACEUTICAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BENZTROPINE MESYLATE TABLET [CAMBER PHARMACEUTICAL, INC.] 1
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 · 1 matching rows.