Home NDC 0143-9233 Benztropine Mesylate
Product NDC 0143-9233
11-digit product format 001439233
Labeler code 0143
Product ID 0143-9233_a86273c1-08ac-4b57-a796-24989c8a2842
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benztropine Mesylate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA209442
Marketing category ANDA
Marketing start 2021-10-14
Substance BENZTROPINE MESYLATE
Active strength 1 mg/mL
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 42 .
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 A209442-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209442-001 AP
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.
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 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209442-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2021-10-14 a50c72e98297…
Observed Orange Book normalized TE history# 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/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 885205 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 0143-9233-01 Benztropine Mesylate 2 mL in 1 VIAL INJECTION 2 5 0143-9233-05 Benztropine Mesylate 5 in 1 BOX INJECTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9233 BENZTROPINE MESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240413_accd7e33-ca6e-46e6-a2ae-20b9bcd8fb89.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9233-01 00143923301 2 mL in 1 VIAL 2 ml Historical 0143-9233-05 00143923305 5 VIAL in 1 BOX (0143-9233-05) / 2 mL in 1 VIAL (0143-9233-01) 5 vial 2021-10-14 0000-00-00 No No Current