CLOMIPRAMINE HYDROCHLORIDE

Product NDC: 60429-289
Requested package NDC: 60429-289-01
11-digit product format: 604290289
Labeler code: 60429
Product ID: 60429-289_9e7bd8c2-eb5c-d570-e053-2a95a90a885d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clomipramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Golden State Medical Supply
Application: ANDA074694
Marketing category: ANDA
Marketing start: 1996-12-31
Marketing end: 0000-00-00
Substance: CLOMIPRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60429-289	60429-289-01	D	Discontinued by firm		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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A074694-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31
A074694-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31
A074694-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074694-001	AB
A074694-002	AB
A074694-003	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	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`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	A074694-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074694-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074694-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074694-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074694-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-289-01	EA - Each	60429-289	4f34b0e4-f57c-4a5d-8723-bae46095535b	1	2015-08-04
60429-289-30	EA - Each	60429-289	d2dea1da-1662-4682-a3cf-c61589397369	1	2012-07-24
60429-289-90	EA - Each	60429-289	630c0514-80f1-4495-934d-24a0f9cc6aa0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clomipramine Hydrochloride	ACTIVE INGREDIENT	2LXW0L6GWJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Clomipramine	ACTIVE MOIETY	NUV44L116D	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3

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
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Major Pharmaceuticals	eff91018-5a5e-4426-96ae-71ecd82273b7	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	fa2eb38c-b155-0d53-e053-6294a90a1d29	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	American Health Packaging	1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2LXW0L6GWJ	CLOMIPRAMINE HYDROCHLORIDE	17321-77-6	CLOMIPRAMINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60429-289-01	60429028901	100 CAPSULE in 1 BOTTLE (60429-289-01)	100 capsule	2012-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ClomiPRAMINE Hydrochloride Capsules USP	Golden State Medical Supply	2020-03-04	HUMAN PRESCRIPTION DRUG LABEL	8