FDA.reportPublic FDA data

NDC 63629-8675-01 - Ketoconazole

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
63629-8675
Requested NDC
63629-8675-01
Package NDCs from labels
63629-8675-1, 63629-8675-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketoconazole - Bryant Ranch PrepackBryant Ranch Prepack2024-03-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8675-1Ketoconazole120 mL in 1 BOTTLESHAMPOO, SUSPENSION120107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8675KETOCONAZOLE SHAMPOO, SUSPENSION [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20240808_b200ef76-5ea1-4253-bea5-1e8db0294510.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8675-1ML - Milliliter63629-8675975c7a79-3159-415f-8d66-5ffd8bac1ff912023-08-08

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 11 of 56 · 1,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ketoconazoleKETOCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCcad7c647-34a9-4e4e-83b3-8d78e58f588f2026-01-28Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLENORTHSTAR RX LLCbf3e48fd-e063-42e6-acd1-580ddc6e93be2026-01-26Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
KetoconazoleKETOCONAZOLE CREAM, 2%ASCLEMED USA INC.6f1a5365-99df-4169-9382-14c2643e561d2026-01-23Warnings, Adverse reactionsExact identifier
unii: R9400W927I
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
KetoconazoleKETOCONAZOLE CREAM, 2%Sportpharm LLCd68f090d-82ea-413f-ab76-9254a88887362026-01-19Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.482c0243-1073-f578-e063-6294a90adf5c2026-01-15WarningsExact identifier
unii: R9400W927I
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: 451W47IQ8X
LuffaLUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTAMarco Pharma International LLC.7dbb79de-c3f5-4245-884a-a6bd29bb861c2026-01-12WarningsExact identifier
unii: 451W47IQ8X
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 451W47IQ8X
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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