FDA.reportPublic FDA data

NDC 70518-3221-01 - CEFIXIME

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
70518-3221
Requested NDC
70518-3221-01
Package NDCs from labels
70518-3221-1, 70518-3221-0, 70518-3221-3, 70518-3221-2, 70518-3221-4, 70518-3221-5, 70518-3221-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CEFIXIME - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3221-0CEFIXIME2 in 1 BOXCAPSULE29
70518-3221-1CEFIXIME1 in 1 POUCHCAPSULE19
70518-3221-2CEFIXIME2 in 1 BOXCAPSULE29
70518-3221-3CEFIXIME1 in 1 POUCHCAPSULE19
70518-3221-4CEFIXIME2 in 1 BOTTLE, PLASTICCAPSULE29
70518-3221-5CEFIXIME2 in 1 BOTTLE, PLASTICCAPSULE29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3221CEFIXIME CAPSULE [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 6 package rows20240927_3194433c-c04e-442b-9668-fbeb0a15bac7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3221-1EA - Each70518-32218a439962-d641-437a-bfd5-b222341aa8cc12024-04-05
70518-3221-2EA - Each70518-32210135676c-0db8-4f7e-b938-bdd3e657c6d412024-04-05
70518-3221-3EA - Each70518-3221841e4149-5df0-4e2c-b485-fcc15beefced12026-02-05
70518-3221-4EA - Each70518-3221d121acf6-3c3c-4f23-85e3-e7aaf525406212024-04-05

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 70 of 137 · 2,723 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICADONG IL PHARMS CO.,LTD41198822-7c8f-ceb2-e063-6394a90a43732025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD41197bb6-f6f4-c86d-e063-6294a90ad4762025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
CEFIXIMECEFIXIMELupin Pharmaceuticals, Inc.6d68dbd9-7d75-4ff1-91db-79ff8ae879ec2025-10-14Warnings, Adverse reactionsExact identifier
application number: NDA203195
ndc (product): 68180-423
rxcui: 309058
rxcui: 419849
rxcui: 409823
spl id: 735f86f4-369c-4f5a-adbe-7dacea2e27b4
spl set id: 6d68dbd9-7d75-4ff1-91db-79ff8ae879ec
unii: 97I1C92E55
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd4114ab09-1115-6b0b-e063-6394a90ab4422025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd41155922-d7ac-0a7a-e063-6294a90afe482025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD41157552-2473-176b-e063-6294a90a9ad02025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd4115d122-3090-d3e5-e063-6294a90aafb62025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD4115b653-63ff-703f-e063-6294a90a652a2025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
Silicea BelladonnaSILICEA BELLADONNAUriel Pharmacy Inc.a142eb87-c5fb-4138-bc98-e7f1391fe2212025-10-10WarningsExact identifier
unii: ETJ7Z6XBU4
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
unii: 15FIX9V2JP
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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