Imipramine Hydrochloride

Product NDC: 72789-492
11-digit product format: 727890492
Labeler code: 72789
Product ID: 72789-492_4dee544b-dd2e-6649-e063-6394a90a5b52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Imipramine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA040903
Marketing category: ANDA
Marketing start: 2016-04-07
Substance: IMIPRAMINE HYDROCHLORIDE
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 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	RLD / RS	Approval date
A040903-001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24
A040903-002	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24
A040903-003	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040903-001	AB
A040903-002	AB
A040903-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040903-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2012-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040903-003	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2012-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040903-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-10-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A040903-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040903-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040903-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040903-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040903-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040903-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040903-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040903-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040903-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040903-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040903-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040903-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040903-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040903-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040903-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040903-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040903-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040903-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040903-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040903-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040903-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040903-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040903-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040903-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040903-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040903-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040903-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040903-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040903-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040903-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040903-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040903-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040903-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

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
649837df-147f-436c-9553-32ffecf4c6f1	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	Strength	SPL version
72789-492-01	Imipramine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		19
72789-492-95	Imipramine Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-492-01	EA - Each	72789-492	fff7e047-40fb-4332-8ef5-f4550b2977be	1	2025-10-14
72789-492-95	EA - Each	72789-492	2a0a27a5-0b53-458b-99a9-39960706c547	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-492	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	16	Current NDC, 2 package rows	20250312_649837df-147f-436c-9553-32ffecf4c6f1.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Leading Pharma, LLC	490263ce-b4d2-428a-87da-fcd07f85499a	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	A-S Medication Solutions	d9dbcebe-9aba-4a93-a7b7-48d29e07d3c4	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7091ff32-55b9-48fd-a86d-c502af57473f	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	649837df-147f-436c-9553-32ffecf4c6f1	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903 ndc (product): 72789-492
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	bcd3b62a-88d4-49eb-b0aa-71e28cf40919	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	db007ac0-020e-4962-8903-7497ab96a74e	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Coupler LLC	48e8b819-a9a0-aa5a-e063-6394a90ad9c2	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	20af582f-08ba-4281-a2df-0bcf68c58594	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903
Imipramine hydrochloride	IMIPRAMINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f887062a-7c82-664f-e053-6294a90a2773	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Proficient Rx LP	3f90b8dd-7234-4428-b896-943d052dd05f	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040903 application number: ANDA040903

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	649837df-147f-436c-9553-32ffecf4c6f1	19
835564	imipramine hydrochloride 25 MG Oral Tablet	SCD	649837df-147f-436c-9553-32ffecf4c6f1	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72789-492-01	72789049201	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-492-01)	2025-03-10	No	No	Current
72789-492-95	72789049295	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-492-95)	2025-03-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imipramine Hydrochloride Tablets, USP 25 mg Rx only Prescribing Information	PD-Rx Pharmaceuticals, Inc.	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL	19