Clomipramine HCl

Product NDC: 69238-1108
11-digit product format: 692381108
Labeler code: 69238
Product ID: 69238-1108_c4aef914-a0aa-487b-a9d4-b4357ec400d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clomipramine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA208632
Marketing category: ANDA
Marketing start: 2018-10-31
Marketing end: 0000-00-00
Substance: CLOMIPRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	69238-1108		D	Discontinued by firm	2026-10-16
excluded package	package	69238-1108	69238-1108-3	D	Discontinued by firm	2026-10-16
excluded package	package	69238-1108	69238-1108-9	D	Discontinued by firm	2026-10-16

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69238-1108		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69238-1108	69238-1108-9	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69238-1108	69238-1108-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A208632-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2018-10-31
A208632-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2018-10-31
A208632-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2018-10-31

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 · 132 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
2026-10-15 13:18:30	2026-09	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208632-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208632-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208632-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-10-31	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A208632-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208632-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208632-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208632-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208632-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208632-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208632-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208632-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208632-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208632-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208632-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208632-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208632-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208632-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208632-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208632-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208632-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208632-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208632-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208632-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208632-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208632-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208632-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208632-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208632-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208632-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208632-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208632-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208632-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208632-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208632-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208632-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208632-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208632-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208632-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208632-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208632-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208632-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208632-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208632-002	AB	1	`a67488948f0b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1108-3	EA - Each	69238-1108	db1b8c77-06af-4bc8-868e-d30e83f5685a	1	2019-02-13
69238-1108-9	EA - Each	69238-1108	fb79c510-121f-497f-b1d4-b10d7f5f7099	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1108	CLOMIPRAMINE HCL CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]	11	Legacy NDC	20241218_b1739aa5-69d8-4a69-be58-6d789ea2a516.zip

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
69238-1108-3	69238110803	30 CAPSULE in 1 BOTTLE (69238-1108-3)	30 capsule	2018-10-31	0000-00-00	No	No	Current
69238-1108-9	69238110809	90 CAPSULE in 1 BOTTLE (69238-1108-9)	90 capsule	2018-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx only	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited	2024-12-09	HUMAN PRESCRIPTION DRUG LABEL	11