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 34 of 63 · 1,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM79CARDUUS MAR, HYDRASTIS, KALI MUR, PHYTOLACCIN, POLYGONUM, RUTABestmade Natural Products2cf029ac-5560-84fb-e063-6294a90a06202025-01-30WarningsExact identifier
unii: 660YQ98I10
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: 660YQ98I10
Kali Carbonicum Kit RefillPOTASSIUM CARBONATEWashington Homeopathic Productsdfdb7ca2-8b15-683b-e053-2995a90a3f612025-01-28WarningsExact identifier
unii: BQN1B9B9HA
Kali Muriaticum Kit RefillPOTASSIUM CHLORIDEWashington Homeopathic Products099223af-a3f6-c370-e063-6394a90aa17f2025-01-28WarningsExact identifier
unii: 660YQ98I10
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC2ccaf945-0369-3129-e063-6394a90a27402025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075731
ndc (package): 67046-1501-3
ndc (product): 67046-1501
rxcui: 197464
spl id: 2ccafa6f-08ea-91c7-e063-6294a90aa353
spl set id: 2ccaf945-0369-3129-e063-6394a90a2740
unii: 63FN7G03XY
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Kali Mur (Lactose-Free)KALI MURIATICUMBestmade Natural Products2c4ae2c0-6ba0-e1dc-e063-6294a90a03652025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
Bestmade Natural Products Bio5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Productsea22e5e7-491a-91ac-e053-2a95a90a44142025-01-22WarningsExact identifier
unii: 660YQ98I10
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rxf988aa11-60ef-411e-e053-6294a90a522a2025-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Productsea233792-038f-39e7-e053-2995a90a20ad2025-01-22WarningsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEDirect_Rx946b9568-671d-172a-e053-2a95a90ac8272025-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bestmade Natural Products BM5APIS MELD3, BAPTISIAD4, CONIUM MACD8, ECHINACEAD2, EUPATORIUMD4, SILICEAD6, THUJA OCCD8Bestmade Natural Productsebdcb53e-1767-cd08-e053-2995a90aedeb2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM7ECHINACEAD5, GRAPHITESD10, HYDROCOTYLED3, KALI MURD6, PETROLEUMD12, SULPHURD7, VIOLA TRICOLORD5Bestmade Natural Productsec16dd97-9407-5aef-e053-2a95a90af5b02025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio9FERR PHOS, KALI MUR, KALI PHOS, MAG PHOSBestmade Natural Productsea4dbb5b-9a48-0710-e053-2995a90ae3882025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio10CALC PHOS, FERR PHOS, KALI MURBestmade Natural Productsea63db39-136e-6098-e053-2995a90aa6182025-01-22WarningsExact identifier
unii: 660YQ98I10
Bestmade Natural Products Bio11FERR PHOS, KALI MUR, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseaa202d7-4297-57ba-e053-2995a90a02952025-01-22WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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