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 25 of 63 · 1,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Owell Naturals Draw SalveARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1536ff1e-16b8-fbbc-e063-6394a90a628e2025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4
KabivenDEXTROSE, 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, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEPreferred Pharmaceuticals Inc.87f369cf-40e5-4f91-aa42-ae986fce65442025-09-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a42025-09-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3dfa63fc-f8de-f1e0-e063-6294a90a8d472025-09-04Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3dfac7ca-2c2e-e709-e063-6394a90adbb32025-09-04Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEKesin Pharma Corporation440dcbbb-bb31-d3fd-e063-6294a90ab2f72025-09-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions8f6ea056-5e10-4de1-97f0-55f0655a6f782025-08-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions8757d093-747b-4e97-af6d-4064b16178b22025-08-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Allergy and Sinus ReliefPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDESchwabe North American, Inc.c90cc6f5-14ec-41a3-a20a-4e8018bb02fb2025-08-25WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packaging149770d0-3a2c-4e75-80a3-ec842907920d2025-08-25Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Inc.0c3ed6fe-8dce-0496-e063-6394a90add562025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA

Reported adverse events (FAERS/openFDA)#

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