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 81 of 130 · 2,584 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-109ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLEDNA Labs, Inc.7758341d-e0be-487a-ba47-8847551231e12025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
Brush and Go All Skin typesTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd9ee5b3c2-4369-4c4b-ab55-b52661b821882025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Inc5c4219ac-d65f-43a5-8ec4-8732b9b344cf2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Brush and Go Oily Problematic SkinTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdb4295453-f193-4bed-be5b-efcd917721072025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
SUN PROTECT LIP BALM SPF 30ZINC OXIDE AND TITANIUM DIOXIDEStream2Sea, LLC21386652-b952-48be-b077-1acecc7f0eb02025-01-12WarningsExact identifier
unii: 15FIX9V2JP
Dermaroller Anhydrous Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.04e82f1b-c893-4795-b7a9-0523e3ec75522025-01-10WarningsExact identifier
unii: 15FIX9V2JP
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Incbe0da1f0-06a1-11df-8a39-0800200c9a662025-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENEW SEASON DERMATOLOGY, PLLCfecd72a3-c7e5-3dfa-e053-6394a90a73572025-01-09WarningsExact identifier
unii: 15FIX9V2JP
ECLIPSE SPF 50 PERFECTINT BEIGETITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLCb69dda25-372f-15d9-e053-2995a90a8d3e2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
Extreme Protect SPF 40 All ShadesZINC OXIDE, TITANIUM DIOXIDEScience of Skincare, LLC.b69db78b-5f0e-8ca2-e053-2a95a90ac88c2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
ECLIPSE SPF 50 ALL SHADESTITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLC49df51e6-be9a-41be-b3e1-bfc062aaceaa2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
AM-9SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLEDNA Labs, Inc.d7a00f0b-de4c-4bff-b8e0-86a82bed8bb92025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-8SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARYDNA Labs, Inc.c25cdcb5-9469-48bb-b216-0a9d8d644e122025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-23ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.b6365b49-06fb-4692-96f7-a5097b70bc912025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-18OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, NITRIC ACID, AND SUS SCROFA PINEAL GLANDDNA Labs, Inc.3565c5d5-dc68-4f3f-99ec-30f8952393e02025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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