FDA.reportPublic FDA data

NDC 51672-4044-01 - Clorazepate Dipotassium

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
51672-4044
Requested NDC
51672-4044-01
Package NDCs from labels
51672-4044-1, 51672-4044-2, 51672-4044-3, 51672-4044-01
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-09-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clorazepate Dipotassium Tablets USP 15 mgPD-Rx Pharmaceuticals, Inc.2026-09-14HUMAN PRESCRIPTION DRUG LABEL
Clorazepate Dipotassium - Clinical Solutions Wholesale, LLCClinical Solutions Wholesale, LLC2026-07-24HUMAN PRESCRIPTION DRUG LABEL
Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, & 15 mgSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL
Clorazepate Dipotassium - Coupler LLCCoupler LLC2025-01-28HUMAN PRESCRIPTION DRUG LABEL
Clorazepate Dipotassium Tablets USP, 15 mgPD-Rx Pharmaceuticals, Inc.2025-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4044-1Clorazepate Dipotassium100 in 1 BOTTLETABLET1007
51672-4044-2Clorazepate Dipotassium500 in 1 BOTTLETABLET5007
51672-4044-3Clorazepate Dipotassium1000 in 1 BOTTLETABLET10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4044CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 3 package rows20240926_499a6989-8912-44b7-b1eb-ee8f85ae378f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4044-1EA - Each51672-40442dca8912-9c73-4790-a352-6b367bfb3b2012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clorazepate DipotassiumACTIVE INGREDIENT63FN7G03XYCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
Clorazepic AcidACTIVE MOIETYD51WO0G0L4CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
D&C Red No. 6INACTIVE INGREDIENT481744AI4OCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
potassium chlorideINACTIVE INGREDIENT660YQ98I10CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2

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 24 of 63 · 1,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
Tinnitus FormulaCIMICIFUGA RACEMOSA, GINKGO BILOBA, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, SULPHUR, CEREBELLUM (SUIS), EAR (SUIS) DIGITALIS PURPUREA, KALI CARBONICUMNutritional Specialties, Inc.4885c23c-093c-4ea0-8061-83cdeab9902e2025-10-06WarningsExact identifier
unii: BQN1B9B9HA
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.cc15ef60-6956-4d34-b86d-72cdd0c0c0bb2025-10-02Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC40074ed8-0799-e3e0-e063-6394a90ad2002025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075731
rxcui: 197466
unii: 63FN7G03XY
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEGranules Pharmaceuticals Inc.b3d4d5b5-2898-ae3d-e053-2a95a90a6d042025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEGranules Pharmaceuticals Incc1f4832d-4d5c-8c49-e053-2a95a90ac9fe2025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack0e875691-7372-46ac-80a1-946e08b400612025-09-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD3fb16579-7cf1-873a-e063-6294a90a9ac12025-09-26WarningsExact identifier
unii: ETJ7Z6XBU4
Potassium ChloridePOTASSIUM CHLORIDEEpic Pharma, LLC00615fad-ad3b-46e8-a89d-48290d937ae22025-09-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEMacleods Pharmaceuticals Limited89d827c8-91af-4bfd-a846-62e55824e9832025-09-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticalsa9d68a40-75e3-4c5c-b5d7-1d6160527fa72025-09-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Vax-SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI, MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICANutritional Specialties, Inc.cd570e98-c73f-4b38-b5b9-9f16f745ca192025-09-22WarningsExact identifier
unii: ETJ7Z6XBU4
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c334fbd-0c1e-eac0-e053-2995a90a92832025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c348fa7-1d68-4975-e053-2995a90a0ca62025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: BQN1B9B9HA
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labs542e16b0-44db-490f-b44e-4c88a6e3d8b82025-09-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEStrides Pharma Science Limited0224e5b3-3c49-4e6e-aa78-1abcc69692462025-09-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Owell Naturals Draw Salve, Arnica, SiliceaARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1c9dab31-de1f-911b-e063-6294a90a03912025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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