Trimipramine Maleate

Product NDC: 64850-850
Requested package NDC: 64850-850-30
11-digit product format: 648500850
Labeler code: 64850
Product ID: 64850-850_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: 2011-11-21
Substance: TRIMIPRAMINE MALEATE
Active strength: 25 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
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 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077361-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077361-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077361-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077361-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077361-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077361-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Trimipramine Maleate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIMIPRAMINE MALEATE	25 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
59c25dd3-7ab0-4e7f-b839-367db9eeccd2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1c70dfe2-7a86-036d-045f-091057d656a1	Product name	2	20160609

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64850-850-30	Trimipramine Maleate	30 in 1 BOTTLE	CAPSULE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64850-850-30	EA - Each	64850-850	d9a77ebc-2afc-4caa-b023-3a0a4b48430c	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64850-850	TRIMIPRAMINE MALEATE CAPSULE [ELITE LABORATORIES, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20230107_59c25dd3-7ab0-4e7f-b839-367db9eeccd2.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 · 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 (package): 64850-850-30 ndc (product): 64850-850 ndc11 (package): 64850085030

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313498	trimipramine 25 MG Oral Capsule	PSN	e4ff3409-f1bf-4851-a848-be1fcc4b1217	100
313498	trimipramine 25 MG Oral Capsule	SCD	e4ff3409-f1bf-4851-a848-be1fcc4b1217	100
313498	trimipramine 25 MG (as trimipramine maleate ) Oral Capsule	SY	e4ff3409-f1bf-4851-a848-be1fcc4b1217	100
313496	trimipramine 100 MG Oral Capsule	PSN	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2
313498	trimipramine 25 MG Oral Capsule	PSN	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2
313499	trimipramine 50 MG Oral Capsule	PSN	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2
313496	trimipramine 100 MG Oral Capsule	SCD	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2
313498	trimipramine 25 MG Oral Capsule	SCD	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2
313499	trimipramine 50 MG Oral Capsule	SCD	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2
313496	trimipramine 100 MG (as trimipramine maleate ) Oral Capsule	SY	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2
313498	trimipramine 25 MG (as trimipramine maleate ) Oral Capsule	SY	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2
313499	trimipramine 50 MG (as trimipramine maleate ) Oral Capsule	SY	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64850-850-30	64850085030	30 CAPSULE in 1 BOTTLE (64850-850-30)	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	Bryant Ranch Prepack	2023-06-14	HUMAN PRESCRIPTION DRUG LABEL	100
TRIMIPRAMINE MALEATE CAPSULES, 25 MG, 50 MG and 100 MG Rx Only	Elite Laboratories, Inc.	2019-12-29	HUMAN PRESCRIPTION DRUG LABEL	2