Clomipramine Hydrochloride

Product NDC: 52817-280
11-digit product format: 528170280
Labeler code: 52817
Product ID: 52817-280_edabf702-d221-78ba-e053-2995a90ae7bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clomipramine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: TruPharma LLC
Application: ANDA210653
Marketing category: ANDA
Marketing start: 2020-09-01
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

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
A210653-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-04-03
A210653-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-04-03
A210653-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-04-03

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 3 · 120 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	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-04-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-04-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL		2020-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL		2020-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL		2020-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210653-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210653-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210653-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-04-03	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210653-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210653-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210653-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210653-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210653-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210653-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210653-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210653-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210653-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210653-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210653-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210653-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210653-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210653-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210653-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210653-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210653-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210653-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210653-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210653-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A210653-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A210653-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210653-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A210653-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A210653-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210653-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210653-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210653-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210653-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210653-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210653-003	AB	1	`a50c72e98297…`

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
52817-280-10	EA - Each	52817-280	79ea8bbc-eebc-43bc-8ed1-3d2e6d679580	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52817-280	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TRUPHARMA LLC]	3	Legacy NDC	20221118_ac4f5271-83d1-797b-e053-2995a90a4f5e.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
52817-280-10	52817028010	100 CAPSULE in 1 BOTTLE (52817-280-10)	100 capsule	2020-09-01	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	TruPharma LLC \| Tulex Pharmaceuticals, Inc.	2022-11-17	HUMAN PRESCRIPTION DRUG LABEL	3