FDA.reportPublic FDA data

NDC 51672-4012-01 - CLOMIPRAMINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-4012
Requested NDC
51672-4012-01
Package NDCs from labels
51672-4012-6, 51672-4012-4, 51672-4012-5, 51672-4012-1, 51672-4012-01
Manufacturer
Major Pharmaceuticals
Effective date
2025-06-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CLOMIPRAMINE HYDROCHLORIDE - Major PharmaceuticalsMajor Pharmaceuticals2025-06-11HUMAN PRESCRIPTION DRUG LABEL
ClomiPRAMINE Hydrochloride Capsules USPGolden State Medical Supply, Inc.2025-06-02HUMAN PRESCRIPTION DRUG LABEL
ClomiPRAMINE Hydrochloride Capsules USPSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.,2025-05-05HUMAN PRESCRIPTION DRUG LABEL
CLOMIPRAMINE HYDROCHLORIDE - American Health PackagingAmerican Health Packaging2024-10-22HUMAN PRESCRIPTION DRUG LABEL
CLOMIPRAMINE HYDROCHLORIDE - Golden State Medical SupplyGolden State Medical Supply2020-03-04HUMAN PRESCRIPTION DRUG LABEL
ClomiPRAMINE Hydrochloride Capsules USPPhysicians Total Care, Inc.2012-01-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4012-1CLOMIPRAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE10012
51672-4012-4CLOMIPRAMINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE6012
51672-4012-5CLOMIPRAMINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE9012
51672-4012-6CLOMIPRAMINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4012CLOMIPRAMINE HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 4 package rows20250507_db752dbd-be41-4cdd-8a13-ed1ff9ef7461.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4012-1EA - Each51672-4012f10f2a2e-638b-4a5c-8a4e-71c7d33cd50412023-09-05
51672-4012-5EA - Each51672-4012a0c2946a-8627-45f5-9dbb-dfce68a3d93a12012-07-24
51672-4012-6EA - Each51672-40122f7b8910-ad3c-4ced-ac5c-8070aad5a59712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clomipramine HydrochlorideACTIVE INGREDIENT2LXW0L6GWJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
ClomipramineACTIVE MOIETYNUV44L116DCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
GelatinINACTIVE INGREDIENT2G86QN327LCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Magnesium StearateINACTIVE INGREDIENT70097M6I30CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Starch, CornINACTIVE INGREDIENTO8232NY3SJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Clomipramine HydrochlorideACTIVE INGREDIENT2LXW0L6GWJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
ClomipramineACTIVE MOIETYNUV44L116DCLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
GelatinINACTIVE INGREDIENT2G86QN327LCLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]3
Clomipramine HydrochlorideACTIVE INGREDIENT2LXW0L6GWJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ClomipramineACTIVE MOIETYNUV44L116DCLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTCLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GelatinINACTIVE INGREDIENT2G86QN327LCLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCLOMIPRAMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
Clomipramine HydrochlorideACTIVE INGREDIENT2LXW0L6GWJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
ClomipramineACTIVE MOIETYNUV44L116DCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
GelatinINACTIVE INGREDIENT2G86QN327LCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCLOMIPRAMINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]1

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 13 of 132 · 2,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
unii: 15FIX9V2JP
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Sinus DefenseLAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC9c2f51c5-aa41-414e-a966-32e02e9e79a22026-04-02WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.