Home NDC 64850-852 Trimipramine Maleate
Product NDC 64850-852
11-digit product format 648500852
Labeler code 64850
Product ID 64850-852_5aa33d8f-3fbf-4109-8335-c9e8e150e5bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trimipramine Maleate
Dosage form CAPSULE
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA077361
Marketing category ANDA
Marketing start 2011-10-21
Substance TRIMIPRAMINE MALEATE
Active strength 100 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
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 1 .
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 A077361-001 TRIMIPRAMINE MALEATE TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 A077361-002 TRIMIPRAMINE MALEATE TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 A077361-003 TRIMIPRAMINE MALEATE TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 123 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 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077361-002 TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE / ORAL AB 2006-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077361-003 TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE / ORAL AB 2006-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077361-001 TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE / ORAL AB 2006-08-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trimipramine Maleate TRIMIPRAMINE MALEATE Bryant Ranch Prepack 326ef804-8d3a-425e-8513-8c9811856aa0 2023-06-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077361 application number: ANDA077361 Trimipramine Maleate TRIMIPRAMINE MALEATE Bryant Ranch Prepack e4ff3409-f1bf-4851-a848-be1fcc4b1217 2023-06-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077361 application number: ANDA077361 Trimipramine Maleate TRIMIPRAMINE MALEATE Bryant Ranch Prepack 479c7dc5-61e1-4bf2-b0bd-5d80865192af 2023-06-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077361 application number: ANDA077361 Trimipramine Maleate TRIMIPRAMINE MALEATE Elite Laboratories, Inc. 59c25dd3-7ab0-4e7f-b839-367db9eeccd2 2019-12-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077361 application number: ANDA077361 ndc (product): 64850-852
Additional Listing Data#
Finished product Yes
Brand name base Trimipramine Maleate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIMIPRAMINE MALEATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 269K6498LD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313496 Internal RxNorm lookup 313498 Internal RxNorm lookup 313499 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 64850-852-30 Trimipramine Maleate 30 in 1 BOTTLE CAPSULE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-852 TRIMIPRAMINE MALEATE CAPSULE [ELITE LABORATORIES, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20230107_59c25dd3-7ab0-4e7f-b839-367db9eeccd2.zip
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 64850-852-30 64850085230 30 CAPSULE in 1 BOTTLE (64850-852-30) 30 capsule 2018-08-31 0000-00-00 No No Current