Imipramine Hydrochloride

Product NDC: 80425-0342
11-digit product format: 804250342
Labeler code: 80425
Product ID: 80425-0342_2a9c2eb6-a6db-f647-e063-6294a90a93fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Imipramine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA040751
Marketing category: ANDA
Marketing start: 2023-06-06
Substance: IMIPRAMINE HYDROCHLORIDE
Active strength: 25 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 42.

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
A040751-001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28
A040751-002	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28
A040751-003	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040751-001	AB
A040751-002	AB
A040751-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040751-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040751-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040751-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040751-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040751-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040751-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040751-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040751-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040751-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040751-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040751-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040751-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040751-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Imipramine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IMIPRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BKE5Q1J60U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835564	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
fd78fb8e-99ae-91b0-e053-6394a90a9271	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0e0df1b-51aa-4301-873c-732ab0ec1631	Product name	1	20170614
0c52f100-e529-4cfc-bd59-334f3eea0233	Product name	1	20151110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0342-1	Imipramine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
80425-0342-2	Imipramine Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
80425-0342-3	Imipramine Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0342-1	EA - Each	80425-0342	dde2fdcb-29e6-40f6-b1e2-91340726269f	1	2023-07-06
80425-0342-2	EA - Each	80425-0342	a1752b69-50a9-4892-96b0-0ce0af54dca3	1	2023-07-06
80425-0342-3	EA - Each	80425-0342	3b7893e8-a32e-476d-b314-daff78ea3697	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0342	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	4	Current NDC, 3 package rows	20250102_fd78fb8e-99ae-91b0-e053-6394a90a9271.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	830cb1cb-20a1-4617-a748-24241257a244	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	02c19a0a-3d9d-4881-ad14-1687aafd87b5	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	a5f60cf1-6f14-40a3-a794-9d69b28088d8	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Proficient Rx LP	5997822f-ce83-4091-be71-21a6b01caaba	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	fd78fb8e-99ae-91b0-e053-6394a90a9271	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751 ndc (product): 80425-0342
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Key Therapeutics	9c685c94-64cd-442a-ade7-193c62d7a058	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	209cc339-658a-577a-e063-6394a90a2b47	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BKE5Q1J60U	IMIPRAMINE HYDROCHLORIDE	113-52-0	IMIPRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
835564	imipramine HCl 25 MG Oral Tablet	PSN	fd78fb8e-99ae-91b0-e053-6394a90a9271	4
835564	imipramine hydrochloride 25 MG Oral Tablet	SCD	fd78fb8e-99ae-91b0-e053-6394a90a9271	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0342-1	80425034201	30 TABLET, FILM COATED in 1 BOTTLE (80425-0342-1)	2023-06-06	No	No	Current
80425-0342-2	80425034202	60 TABLET, FILM COATED in 1 BOTTLE (80425-0342-2)	2023-06-06	No	No	Current
80425-0342-3	80425034203	90 TABLET, FILM COATED in 1 BOTTLE (80425-0342-3)	2023-06-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imipramine Hydrochloride Tablet	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	4