Home NDC 63323-970 BENZTROPINE MESYLATE
Product NDC 63323-970
11-digit product format 633230970
Labeler code 63323
Product ID 63323-970_11222231-55b1-48ee-a8f8-3385f1a2eb36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BENZTROPINE MESYLATE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA090233
Marketing category ANDA
Marketing start 2011-05-31
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 A090233-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090233-001 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 · 42 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 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090233-001 BENZTROPINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2009-07-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 63323-970-02 BENZTROPINE MESYLATE 2 mL in 1 VIAL INJECTION, SOLUTION 2 6 63323-970-02 BENZTROPINE MESYLATE 5 in 1 BOX INJECTION, SOLUTION 5 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZTROPINE MESYLATE ACTIVE INGREDIENT WMJ8TL7510 BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 BENZTROPINE ACTIVE MOIETY 1NHL2J4X8K BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-970 BENZTROPINE MESYLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241018_b03bd28e-3b44-41e4-9a7e-28b9d7975245.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 63323-970-02 63323097002 5 VIAL in 1 BOX (63323-970-02) / 2 mL in 1 VIAL 5 vial 2011-05-31 0000-00-00 No No Current