Clomipramine Hydrochloride

Product NDC: 69315-166
11-digit product format: 693150166
Labeler code: 69315
Product ID: 69315-166_48996a58-a312-4a01-ba38-0261a18bec65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clomipramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA211364
Marketing category: ANDA
Marketing start: 2020-03-10
Substance: CLOMIPRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A211364-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07
A211364-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07
A211364-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211364-001	AB
A211364-002	AB
A211364-003	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 3 · 114 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	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211364-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	2020-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211364-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	2020-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211364-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2020-02-07	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A211364-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211364-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211364-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211364-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211364-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211364-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211364-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211364-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211364-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211364-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211364-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211364-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211364-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211364-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211364-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211364-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211364-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211364-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211364-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211364-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211364-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211364-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211364-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211364-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211364-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211364-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211364-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211364-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211364-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211364-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211364-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211364-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211364-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211364-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211364-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211364-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211364-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211364-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211364-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211364-001	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	50 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
fa0d4de8-c96e-429d-a65c-928afbf46863	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
69315-166-01	Clomipramine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	10
69315-166-03	Clomipramine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	10
69315-166-09	Clomipramine Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-166	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [LEADING PHARMA, LLC]	9	Current NDC, Legacy NDC, 3 package rows	20241212_fa0d4de8-c96e-429d-a65c-928afbf46863.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clomipramine Hydrochloride	CLOMIPRAMINE HYDROCHLORIDE	Leading Pharma, LLC	fa0d4de8-c96e-429d-a65c-928afbf46863	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211364 application number: ANDA211364 ndc (product): 69315-166
Clomipramine Hydrochloride	CLOMIPRAMINE HYDROCHLORIDE	Proficient Rx LP	ff9ed80e-d692-494f-9741-a9af30fa5000	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211364 application number: ANDA211364

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	fa0d4de8-c96e-429d-a65c-928afbf46863	10
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	fa0d4de8-c96e-429d-a65c-928afbf46863	10
857305	clomiPRAMINE HCl 75 MG Oral Capsule	PSN	fa0d4de8-c96e-429d-a65c-928afbf46863	10
857297	clomipramine hydrochloride 25 MG Oral Capsule	SCD	fa0d4de8-c96e-429d-a65c-928afbf46863	10
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	fa0d4de8-c96e-429d-a65c-928afbf46863	10
857305	clomipramine hydrochloride 75 MG Oral Capsule	SCD	fa0d4de8-c96e-429d-a65c-928afbf46863	10
857297	clomiPRAMINE HCl 25 MG Oral Capsule	PSN	ff9ed80e-d692-494f-9741-a9af30fa5000	2
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	ff9ed80e-d692-494f-9741-a9af30fa5000	2
857305	clomiPRAMINE HCl 75 MG Oral Capsule	PSN	ff9ed80e-d692-494f-9741-a9af30fa5000	2
857297	clomipramine hydrochloride 25 MG Oral Capsule	SCD	ff9ed80e-d692-494f-9741-a9af30fa5000	2
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	ff9ed80e-d692-494f-9741-a9af30fa5000	2
857305	clomipramine hydrochloride 75 MG Oral Capsule	SCD	ff9ed80e-d692-494f-9741-a9af30fa5000	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69315-166-01	69315016601	100 CAPSULE in 1 BOTTLE (69315-166-01)	100 capsule	2020-03-10	0000-00-00	No	No	Current
69315-166-03	69315016603	30 CAPSULE in 1 BOTTLE (69315-166-03)	30 capsule	2020-03-10	0000-00-00	No	No	Current
69315-166-09	69315016609	90 CAPSULE in 1 BOTTLE (69315-166-09)	90 capsule	2020-03-10	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	Leading Pharma, LLC \| Ixora Lifescience LLP	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	10
Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx only	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	2