Trimipramine Maleate

Product NDC: 68462-806
Requested package NDC: 68462-806-30
11-digit product format: 684620806
Labeler code: 68462
Product ID: 68462-806_9dcce63b-19d3-4ac7-908b-f1465cf124af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trimipramine Maleate
Dosage form: CAPSULE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc.,USA
Application: ANDA077361
Marketing category: ANDA
Marketing start: 2011-10-21
Marketing end: 0000-00-00
Substance: TRIMIPRAMINE MALEATE
Active strength: 100 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68462-806	68462-806-30	D	Discontinued by firm		2026-08-03

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 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

Application-product, TE code table
Application-product	TE code
A077361-001	AB
A077361-002	AB
A077361-003	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077361-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077361-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077361-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077361-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077361-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077361-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077361-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077361-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077361-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077361-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-806-30	EA - Each	68462-806	2e5858f1-a81d-4419-b968-e336c08f9bdc	1	2019-04-11

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
269K6498LD	TRIMIPRAMINE MALEATE	521-78-8	TRIMIPRAMINE MALEATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-806-30	68462080630	30 CAPSULE in 1 BOTTLE (68462-806-30)	30 capsule	2018-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIMIPRAMINE MALEATE CAPSULES, 25 MG, 50 MG and 100 MG Rx Only	Glenmark Pharmaceuticals Inc.,USA \| Elite Laboratories, Inc.	2019-05-31	HUMAN PRESCRIPTION DRUG LABEL	2