CLOMIPRAMINE HYDROCHLORIDE

Product NDC: 51672-4012
11-digit product format: 516724012
Labeler code: 51672
Product ID: 51672-4012_34699b9e-d070-64b2-e063-6294a90a0f6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clomipramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA074694
Marketing category: ANDA
Marketing start: 1996-12-31
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
A074694-001	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31
A074694-002	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31
A074694-003	CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074694-001	AB
A074694-002	AB
A074694-003	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 4 · 126 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	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-002	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-003	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE / ORAL	AB	1996-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074694-001	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	1996-12-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A074694-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074694-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074694-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074694-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074694-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074694-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074694-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074694-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074694-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074694-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074694-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074694-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074694-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074694-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074694-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074694-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074694-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074694-001	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
db752dbd-be41-4cdd-8a13-ed1ff9ef7461	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
51672-4012-1	CLOMIPRAMINE HYDROCHLORIDE	100 in 1 BOTTLE	CAPSULE	100	12
51672-4012-4	CLOMIPRAMINE HYDROCHLORIDE	60 in 1 BOTTLE	CAPSULE	60	12
51672-4012-5	CLOMIPRAMINE HYDROCHLORIDE	90 in 1 BOTTLE	CAPSULE	90	12
51672-4012-6	CLOMIPRAMINE HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE	30	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4012-1	EA - Each	51672-4012	f10f2a2e-638b-4a5c-8a4e-71c7d33cd504	1	2023-09-05
51672-4012-5	EA - Each	51672-4012	a0c2946a-8627-45f5-9dbb-dfce68a3d93a	1	2012-07-24
51672-4012-6	EA - Each	51672-4012	2f7b8910-ad3c-4ced-ac5c-8070aad5a597	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clomipramine Hydrochloride	ACTIVE INGREDIENT	2LXW0L6GWJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Clomipramine	ACTIVE MOIETY	NUV44L116D	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
FD&C Red No. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]	4
Clomipramine Hydrochloride	ACTIVE INGREDIENT	2LXW0L6GWJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Clomipramine	ACTIVE MOIETY	NUV44L116D	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Clomipramine Hydrochloride	ACTIVE INGREDIENT	2LXW0L6GWJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
Clomipramine	ACTIVE MOIETY	NUV44L116D	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
Clomipramine Hydrochloride	ACTIVE INGREDIENT	2LXW0L6GWJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
Clomipramine	ACTIVE MOIETY	NUV44L116D	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
FD&C Red No. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4012	CLOMIPRAMINE HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12	Current NDC, Legacy NDC, 4 package rows	20250507_db752dbd-be41-4cdd-8a13-ed1ff9ef7461.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Major Pharmaceuticals	eff91018-5a5e-4426-96ae-71ecd82273b7	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	fa2eb38c-b155-0d53-e053-6294a90a1d29	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694 ndc (product): 51672-4012
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	American Health Packaging	1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074694 application number: ANDA074694

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	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	12
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	12
857305	clomiPRAMINE HCl 75 MG Oral Capsule	PSN	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	12
857297	clomipramine hydrochloride 25 MG Oral Capsule	SCD	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	12
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	12
857305	clomipramine hydrochloride 75 MG Oral Capsule	SCD	db752dbd-be41-4cdd-8a13-ed1ff9ef7461	12
857297	clomiPRAMINE HCl 25 MG Oral Capsule	PSN	1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e	7
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e	7
857297	clomipramine hydrochloride 25 MG Oral Capsule	SCD	1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e	7
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e	7
857297	clomiPRAMINE HCl 25 MG Oral Capsule	PSN	eff91018-5a5e-4426-96ae-71ecd82273b7	5
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	eff91018-5a5e-4426-96ae-71ecd82273b7	5
857297	clomipramine hydrochloride 25 MG Oral Capsule	SCD	eff91018-5a5e-4426-96ae-71ecd82273b7	5
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	eff91018-5a5e-4426-96ae-71ecd82273b7	5
857297	clomiPRAMINE HCl 25 MG Oral Capsule	PSN	fa2eb38c-b155-0d53-e053-6294a90a1d29	3
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	fa2eb38c-b155-0d53-e053-6294a90a1d29	3
857305	clomiPRAMINE HCl 75 MG Oral Capsule	PSN	fa2eb38c-b155-0d53-e053-6294a90a1d29	3
857297	clomipramine hydrochloride 25 MG Oral Capsule	SCD	fa2eb38c-b155-0d53-e053-6294a90a1d29	3
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	fa2eb38c-b155-0d53-e053-6294a90a1d29	3
857305	clomipramine hydrochloride 75 MG Oral Capsule	SCD	fa2eb38c-b155-0d53-e053-6294a90a1d29	3
857301	clomiPRAMINE HCl 50 MG Oral Capsule	PSN	33c772f8-08f0-4f99-8fbd-4de48ad82d89	2
857301	clomipramine hydrochloride 50 MG Oral Capsule	SCD	33c772f8-08f0-4f99-8fbd-4de48ad82d89	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4012-1	51672401201	100 CAPSULE in 1 BOTTLE (51672-4012-1)	100 capsule	1996-12-31	0000-00-00	No	No	Current
51672-4012-4	51672401204	60 CAPSULE in 1 BOTTLE (51672-4012-4)	60 capsule	1996-12-31	0000-00-00	No	No	Current
51672-4012-5	51672401205	90 CAPSULE in 1 BOTTLE (51672-4012-5)	90 capsule	1996-12-31	0000-00-00	No	No	Current
51672-4012-6	51672401206	30 CAPSULE in 1 BOTTLE (51672-4012-6)	30 capsule	1996-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ClomiPRAMINE Hydrochloride Capsules USP	Major Pharmaceuticals	2025-06-11	HUMAN PRESCRIPTION DRUG LABEL	5
ClomiPRAMINE Hydrochloride Capsules USP	Golden State Medical Supply, Inc.	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	3
ClomiPRAMINE Hydrochloride Capsules USP	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries Ltd.,	2025-05-05	HUMAN PRESCRIPTION DRUG LABEL	12
ClomiPRAMINE Hydrochloride Capsules USP 8279021/0920F Rx Only	American Health Packaging	2024-10-22	HUMAN PRESCRIPTION DRUG LABEL	7
ClomiPRAMINE Hydrochloride Capsules USP	Golden State Medical Supply	2020-03-04	HUMAN PRESCRIPTION DRUG LABEL	8
ClomiPRAMINE Hydrochloride Capsules USP	Physicians Total Care, Inc.	2012-01-06	HUMAN PRESCRIPTION DRUG LABEL	2