Clomipramine Hydrochloride

Product NDC: 72664-215
11-digit product format: 726640215
Labeler code: 72664
Product ID: 72664-215_c5721d3a-16d2-c1e1-e053-2a95a90a2189
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clomipramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: VGYAAN Pharmaceuticals LLC
Application: ANDA213221
Marketing category: ANDA
Marketing start: 2021-07-01
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: 2022-12-31
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	72664-215		I	Inactivated by FDA	2026-08-07
excluded package	package	72664-215	72664-215-30	I	Inactivated by FDA	2026-08-07
excluded package	package	72664-215	72664-215-90	I	Inactivated by FDA	2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213221-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22
A213221-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22
A213221-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22

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 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213221-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	2020-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213221-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	2020-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213221-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	2020-06-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213221-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213221-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213221-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213221-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213221-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213221-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213221-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213221-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213221-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213221-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213221-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213221-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213221-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213221-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213221-003	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213221-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213221-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213221-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213221-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213221-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213221-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213221-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213221-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213221-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213221-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213221-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213221-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213221-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213221-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213221-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213221-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213221-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213221-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213221-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213221-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213221-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213221-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213221-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213221-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213221-001	AB	1	`3bdfa0b2c4d7…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72664-215-30	2026-01-29	C162847	48780-1	49896155-bec6-586f-e063-e6dba90add90	Clomipramine Hydrochloride Capsules, USP 25 mg, 50 mg and 75 mg. Rx Only
72664-215-90	2026-01-29	C162847	48780-1	49896155-bec6-586f-e063-e6dba90add90	Clomipramine Hydrochloride Capsules, USP 25 mg, 50 mg and 75 mg. Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72664-215-30	Clomipramine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30		8
72664-215-90	Clomipramine Hydrochloride	90 in 1 BOTTLE	CAPSULE	90		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72664-215-90	EA - Each	72664-215	bbfe98f8-5632-4a0e-9cd2-a0c72eaffc1e	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72664-215	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [VGYAAN PHARMACEUTICALS LLC]	8	Legacy NDC, 2 package rows	20230923_9051b489-eba0-4ffa-a577-6dd9d918285d.zip

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	9051b489-eba0-4ffa-a577-6dd9d918285d	8
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	9051b489-eba0-4ffa-a577-6dd9d918285d	8
857305	clomiPRAMINE HCl 75 MG Oral Capsule	PSN	9051b489-eba0-4ffa-a577-6dd9d918285d	8
857297	clomipramine hydrochloride 25 MG Oral Capsule	SCD	9051b489-eba0-4ffa-a577-6dd9d918285d	8
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	9051b489-eba0-4ffa-a577-6dd9d918285d	8
857305	clomipramine hydrochloride 75 MG Oral Capsule	SCD	9051b489-eba0-4ffa-a577-6dd9d918285d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72664-215-30	72664021530	30 CAPSULE in 1 BOTTLE (72664-215-30)	30 capsule	2020-05-17	0000-00-00	No	No	Current
72664-215-90	72664021590	90 CAPSULE in 1 BOTTLE (72664-215-90)	90 capsule	2020-05-17	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	VGYAAN Pharmaceuticals LLC	2023-09-22	HUMAN PRESCRIPTION DRUG LABEL	8