Clomipramine Hydrochloride

Product NDC: 59651-383
Requested package NDC: 59651-383-11
11-digit product format: 596510383
Labeler code: 59651
Product ID: 59651-383_7d11010e-cf0f-4315-aced-7927a486a1ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clomipramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA216440
Marketing category: ANDA
Marketing start: 2023-03-20
Substance: CLOMIPRAMINE HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished package	package	59651-383	59651-383-11	UNFINISHED	Active or certified unfinished drug listing		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 · 14 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

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
A216440-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20
A216440-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20
A216440-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216440-001	AB
A216440-002	AB
A216440-003	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 2 · 72 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	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216440-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216440-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216440-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2023-03-20	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A216440-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216440-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216440-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216440-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216440-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216440-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216440-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216440-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216440-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216440-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216440-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216440-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216440-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216440-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216440-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216440-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216440-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216440-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216440-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216440-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216440-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216440-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216440-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216440-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216440-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216440-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216440-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216440-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216440-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216440-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216440-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216440-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216440-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216440-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216440-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216440-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216440-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216440-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216440-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216440-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clomipramine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOMIPRAMINE HYDROCHLORIDE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2LXW0L6GWJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857297	Internal RxNorm lookup
857301	Internal RxNorm lookup
857305	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
7d11010e-cf0f-4315-aced-7927a486a1ef	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06ad84c7-ef7f-2b11-27cb-22ae93f433b6	Product name	9	20240422

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59651-383-01	Clomipramine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	1
59651-383-30	Clomipramine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	1
59651-383-90	Clomipramine Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-383-01	EA - Each	59651-383	6c2fb65d-8820-41bd-81d9-0a55ccca92c3	1	2023-06-06
59651-383-30	EA - Each	59651-383	836f0fb8-2598-4cab-82f4-c627361757d6	1	2023-06-06
59651-383-90	EA - Each	59651-383	8843a4c7-5df5-4cad-8364-9b1d80be0eb5	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-383	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	1	Current NDC, 3 package rows	20230408_7d11010e-cf0f-4315-aced-7927a486a1ef.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clomipramine Hydrochloride	CLOMIPRAMINE HYDROCHLORIDE	Aurobindo Pharma Limited	7d11010e-cf0f-4315-aced-7927a486a1ef	2023-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216440 application number: ANDA216440 ndc (product): 59651-383

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857297	clomiPRAMINE HCl 25 MG Oral Capsule	PSN	7d11010e-cf0f-4315-aced-7927a486a1ef	1
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	7d11010e-cf0f-4315-aced-7927a486a1ef	1
857305	clomiPRAMINE HCl 75 MG Oral Capsule	PSN	7d11010e-cf0f-4315-aced-7927a486a1ef	1
857297	clomipramine hydrochloride 25 MG Oral Capsule	SCD	7d11010e-cf0f-4315-aced-7927a486a1ef	1
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	7d11010e-cf0f-4315-aced-7927a486a1ef	1
857305	clomipramine hydrochloride 75 MG Oral Capsule	SCD	7d11010e-cf0f-4315-aced-7927a486a1ef	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
59651-383-11	59651038311	1000 CAPSULE in 1 BAG (59651-383-11)	1000 capsule	20-MAR-23	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	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2023-03-21	Human Prescription Drug Label	1