Home NDC 68475-512 Benztropine Mesylate
Product NDC 68475-512
11-digit product format 684750512
Labeler code 68475
Product ID 68475-512_29929540-0861-42fa-9b0b-6675023ee007
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benztropine Mesylate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Navinta LLC
Application ANDA091525
Marketing category ANDA
Marketing start 2020-11-24
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 2027-12-31
Current FDA listing Yes 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 A091525-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091525-001 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.
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 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091525-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2013-02-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Benztropine Mesylate
Listing expiration 2027-12-31 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 68475-512-01 Benztropine Mesylate 2 mL in 1 VIAL INJECTION 2 6 68475-512-02 Benztropine Mesylate 5 in 1 CARTON INJECTION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68475-512 BENZTROPINE MESYLATE INJECTION [NAVINTA LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241228_f92fbafa-314d-4449-831f-26108339e6b2.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 · 2 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 68475-512-01 68475051201 2 mL in 1 VIAL 2 ml Historical 68475-512-02 68475051202 5 VIAL in 1 CARTON (68475-512-02) / 2 mL in 1 VIAL (68475-512-01) 5 vial 2020-11-24 0000-00-00 No No Current