FDA.reportPublic FDA data

NDC 68025-047-01 - Lorzone

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
68025-047
Requested NDC
68025-047-01
Package NDCs from labels
68025-047-10, 68025-047-01, 68025-047-02
Manufacturer
Vertical Pharmaceuticals, Inc.
Effective date
2023-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LorzoneVertical Pharmaceuticals, Inc.2023-09-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68025-047-10EA - Each68025-0477d8728a7-8b74-4dcd-b339-4d2b5abfe61f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORZOXAZONEACTIVE INGREDIENTH0DE420U8GLORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
CHLORZOXAZONEACTIVE MOIETYH0DE420U8GLORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0LORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORZONE (CHLORZOXAZONE) TABLET [VERTICAL PHARMACEUTICALS, LLC]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 18 of 19 · 373 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corpb595063a-5fee-18c2-e053-2a95a90a5b992023-11-15WarningsExact identifier
unii: F05Q2T2JA0
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP92879e62-f60a-4ab4-9532-610cdd2628ee2023-11-01WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions5999904a-6ac8-4d9e-951c-6e64e8cd93eb2023-11-01WarningsExact identifier
unii: F05Q2T2JA0
Sodium phenylacetate and Sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.0f17c50f-3761-4470-bf3b-63837a287b8a2023-10-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.a0e6ab9b-fd31-45fd-93d5-b51d705c180a2023-10-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESMagno-Humphries, Inc.9deaf264-6af0-40ba-e053-2a95a90ada0e2023-10-27WarningsExact identifier
unii: F05Q2T2JA0
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMKROGER COMPANYa1afaa71-7e8c-5a49-e053-2a95a90a4db02023-10-23WarningsExact identifier
unii: F05Q2T2JA0
SENNA-SSENNA AND DOCUSATE SODIUM TABLETS, 8.6 MG AND 50 MGHealthLife of USA LLC02a5299c-4b0d-47ac-9838-afd0b0fdd4a62023-10-21WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMAsclemed USA, Inc.30fc8c07-c26b-4bcc-a727-6e193f5727fd2023-10-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
unii: F05Q2T2JA0
0684cd50-20cd-772e-e063-6294a90a3ea3bdd61b83-5bcd-4d23-8ef5-aeb9ca2f7c142023-09-29Warnings, Adverse reactionsExact identifier
spl id: 0684cd50-20cd-772e-e063-6294a90a3ea3
spl set id: bdd61b83-5bcd-4d23-8ef5-aeb9ca2f7c14
CHLORZOXAZONECHLORZOXAZONEAurobindo Pharma Limited52d3aa2c-f88f-4de7-b5ae-df8a46e948792023-09-05Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: OJ245FE5EU
ChlorzoxazoneCHLORZOXAZONEMayne Pharma Commercial LLC5238c99e-d36e-4376-ab05-ca2535213d582023-07-06Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALS, INC3529be10-0004-4628-9ca1-67a8acd86b512023-07-05Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
CHLORZOXAZONECHLORZOXAZONERising Pharma Holdings, Inc.1df6058b-7bf2-4246-9827-93fa023a5fd42023-06-09Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G

Reported adverse events (FAERS/openFDA)#

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