Imipramine Hydrochloride

Product NDC: 64125-133
11-digit product format: 641250133
Labeler code: 64125
Product ID: 64125-133_9a23d0f8-191b-4a68-b25a-627e22571373
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Imipramine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Excellium Pharmaceutical, Inc
Application: ANDA040903
Marketing category: ANDA
Marketing start: 2012-11-01
Marketing end: 0000-00-00
Substance: IMIPRAMINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64125-133		I	Inactivated by FDA	2026-08-17
excluded package	package	64125-133	64125-133-01	I	Inactivated by FDA	2026-08-17
excluded package	package	64125-133	64125-133-10	I	Inactivated by FDA	2026-08-17

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64125-133-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64125-133-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64125-133-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64125-133-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64125-133-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64125-133-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64125-133-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64125-133-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64125-133-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64125-133-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64125-133-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64125-133-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64125-133-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64125-133-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64125-133-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64125-133-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64125-133-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64125-133-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64125-133-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64125-133-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64125-133-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64125-133-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64125-133-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64125-133-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64125-133-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64125-133-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64125-133-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64125-133-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64125-133-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64125-133-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64125-133-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64125-133-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64125-133-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64125-133-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64125-133-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64125-133-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64125-133-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64125-133-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64125-133-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64125-133-10	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64125-133-01	2019-11-27	C162847	48780-1	9855d018-e108-cd31-e053-dbdaa90ab51a	Imipramine Hydrochloride Tablets USP 10 mg, 25 mg, and 50 mg
64125-133-10	2019-11-27	C162847	48780-1	9855d018-e108-cd31-e053-dbdaa90ab51a	Imipramine Hydrochloride Tablets USP 10 mg, 25 mg, and 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64125-133-01	Imipramine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		1
64125-133-10	Imipramine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64125-133-01	EA - Each	64125-133	1d5cdea8-2be8-47ac-8c2f-c1f7add9004a	1	2013-04-01
64125-133-10	EA - Each	64125-133	0e3512cb-c300-4574-bead-918d3d8eb162	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IMIPRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	BKE5Q1J60U	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
IMIPRAMINE	ACTIVE MOIETY	OGG85SX4E4	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64125-133	IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [EXCELLIUM PHARMACEUTICAL, INC]	1	Legacy NDC, 2 package rows	20121108_26454960-2551-4301-b2dc-1b9eab4cbf19.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
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
835593	imipramine HCl 10 MG Oral Tablet	PSN	26454960-2551-4301-b2dc-1b9eab4cbf19	1
835564	imipramine HCl 25 MG Oral Tablet	PSN	26454960-2551-4301-b2dc-1b9eab4cbf19	1
835568	imipramine HCl 50 MG Oral Tablet	PSN	26454960-2551-4301-b2dc-1b9eab4cbf19	1
835593	imipramine hydrochloride 10 MG Oral Tablet	SCD	26454960-2551-4301-b2dc-1b9eab4cbf19	1
835564	imipramine hydrochloride 25 MG Oral Tablet	SCD	26454960-2551-4301-b2dc-1b9eab4cbf19	1
835568	imipramine hydrochloride 50 MG Oral Tablet	SCD	26454960-2551-4301-b2dc-1b9eab4cbf19	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64125-133-01	64125013301	100 in 1 BOTTLE	Historical
64125-133-10	64125013310	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imipramine Hydrochloride Tablets USP 10 mg, 25 mg, and 50 mg	Excellium Pharmaceutical, Inc	2012-10-26	HUMAN PRESCRIPTION DRUG LABEL	1