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 3 of 63 · 1,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals LLCf9965f73-e189-423f-bd10-c4a0ed12b4852026-08-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEREMEDYREPACK INC.16c775e4-0dd8-4e9f-b2bf-dd2b639374cf2026-07-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEREMEDYREPACK INC.7ec22e8e-6643-44fe-804d-ca0b0b2666632026-07-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
unii: BQN1B9B9HA
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMClinical Solutions Wholesale, LLC11b72861-64c9-4cdc-9289-c7fa9ea23bf62026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075731
ndc (package): 58118-4042-8
ndc (package): 58118-4044-8
ndc (package): 58118-4043-8
ndc (product): 58118-4043
ndc (product): 58118-4042
ndc (product): 58118-4044
rxcui: 197465
rxcui: 197466
rxcui: 197464
spl id: 57629108-6ad4-cd5a-e063-6394a90a2a1f
spl set id: 11b72861-64c9-4cdc-9289-c7fa9ea23bf6
unii: 63FN7G03XY
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLC02707146-331f-4511-a187-0152fc8bca852026-07-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMSun Pharmaceutical Industries, Inc.499a6989-8912-44b7-b1eb-ee8f85ae378f2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075731
ndc (package): 51672-4043-3
ndc (package): 51672-4043-2
ndc (package): 51672-4044-2
ndc (package): 51672-4042-3
ndc (package): 51672-4043-1
ndc (package): 51672-4042-2
ndc (package): 51672-4044-3
ndc (package): 51672-4042-1
ndc (package): 51672-4044-1
ndc (product): 51672-4042
ndc (product): 51672-4044
ndc (product): 51672-4043
ndc11 (package): 51672404401
rxcui: 197465
rxcui: 197466
rxcui: 197464
spl id: 56998160-f30b-670e-e063-6294a90ac8ff
spl set id: 499a6989-8912-44b7-b1eb-ee8f85ae378f
unii: 63FN7G03XY
Potassium ChloridePOTASSIUM CHLORIDEMajor Pharmaceuticals6c080e51-4eb7-4e96-b29f-eb1cce3813042026-07-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEATLANTIC BIOLOGICALS CORP.104ccc91-2aaf-4bb7-bb64-77c29413f60e2026-07-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Magnesium OxideMAGNESIUM OXIDEWestminster Pharmaceuticals, LLC52eeac0e-94bb-48c3-81dc-578e96406c012026-07-06WarningsExact identifier
unii: 3A3U0GI71G
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHospira, Inc.559a0a8c-a8fe-40a5-b196-21f9308780ab2026-07-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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