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 73 of 130 · 2,584 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
unii: 15FIX9V2JP
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
unii: 15FIX9V2JP
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEMajor Pharmaceuticalseff91018-5a5e-4426-96ae-71ecd82273b72025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074694
ndc (package): 0904-7038-07
ndc (package): 0904-7039-07
ndc (product): 0904-7038
ndc (product): 0904-7039
rxcui: 857301
rxcui: 857297
spl id: b7641ab7-974c-4814-97ba-44cf2ca7e10f
spl set id: eff91018-5a5e-4426-96ae-71ecd82273b7
unii: 2LXW0L6GWJ
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
unii: 15FIX9V2JP
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
SLIMLYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTINThe Wellness Center for Research and Education5067953f-351e-4bb0-b165-8dc62077cdea2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCafa2d42e-b54d-4843-b313-0c44fe5c5d522025-06-06WarningsExact identifier
unii: 15FIX9V2JP
Silicea 6XSILICEA 6XTrue Botanica, LLC2cee8f0b-6d28-75e4-e063-6294a90a2e152025-06-05WarningsExact identifier
unii: ETJ7Z6XBU4
Body Glove Sunscreen SPF 30ZINC OXIDE, TITANIUM DIOXIDESCUBASCREEN LLC1d7a960c-4387-44dc-8d4e-881e21a8ae2e2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d7c8b3-554f-78d9-e063-6394a90a80f32025-06-05Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d80422-943f-3aba-e063-6294a90afb592025-06-05Exact identifier
unii: 15FIX9V2JP
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesf8e178d6-058c-462a-8e59-6721f28ad0402025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences4c7f0257-fa12-40d6-9516-824b0e3a182c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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