Trimipramine

Product NDC: 51991-946
11-digit product format: 519910946
Labeler code: 51991
Product ID: 51991-946_e1cadaf3-e932-4bfb-a8fa-57fb52f7dc67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trimipramine
Dosage form: CAPSULE
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA208127
Marketing category: ANDA
Marketing start: 2017-04-05
Substance: TRIMIPRAMINE MALEATE
Active strength: 100 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51991-946		D	Discontinued by firm		2026-08-03
excluded package	package	51991-946	51991-946-01	D	Discontinued by firm		2026-08-03

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
A208127-001	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15
A208127-002	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15
A208127-003	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208127-001	AB
A208127-002	AB
A208127-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`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	A208127-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208127-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208127-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208127-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimipramine	TRIMIPRAMINE	Breckenridge Pharmaceutical, Inc.	4f31df66-7dc2-1f04-e054-00144ff88e88	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208127 application number: ANDA208127 ndc (product): 51991-946

Additional Listing Data#

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

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4f31df66-7dc2-1f04-e054-00144ff88e88	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
51991-946-01	Trimipramine	100 in 1 BOTTLE	CAPSULE	100		17
51991-946-33	Trimipramine	30 in 1 BOTTLE	CAPSULE	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-946-01	EA - Each	51991-946	2a1c4884-ea16-4d41-b95d-d1f88e7e3193	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-946	TRIMIPRAMINE MALEATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20250209_4f31df66-7dc2-1f04-e054-00144ff88e88.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
269K6498LD	TRIMIPRAMINE MALEATE	521-78-8	TRIMIPRAMINE MALEATE
6S082C9NDT	TRIMIPRAMINE	739-71-9	Trimipramine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313496	trimipramine 100 MG Oral Capsule	PSN	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313498	trimipramine 25 MG Oral Capsule	PSN	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313499	trimipramine 50 MG Oral Capsule	PSN	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313496	trimipramine 100 MG Oral Capsule	SCD	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313498	trimipramine 25 MG Oral Capsule	SCD	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313499	trimipramine 50 MG Oral Capsule	SCD	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313496	trimipramine 100 MG (as trimipramine maleate ) Oral Capsule	SY	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313498	trimipramine 25 MG (as trimipramine maleate ) Oral Capsule	SY	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313499	trimipramine 50 MG (as trimipramine maleate ) Oral Capsule	SY	4f31df66-7dc2-1f04-e054-00144ff88e88	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-946-01	51991094601	100 CAPSULE in 1 BOTTLE (51991-946-01)	100 capsule	2017-04-05	0000-00-00	No	No	Current
51991-946-33	51991094633	30 CAPSULE in 1 BOTTLE (51991-946-33)	30 capsule	2019-06-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIMIPRAMINE CAPSULES	Breckenridge Pharmaceutical, Inc. \| Rivopharm SA \| LabAnalysis Srl \| Lundbeck Pharmaceuticals Italy S.p.A. \| PCL Research&Manufacturing Srl \| PRC Ticinum Lab S.r.l \| Redox Srl	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	17