FDA.reportPublic FDA data

NDC 63323-340-21 - Cefepime

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
63323-340
Requested NDC
63323-340-21
Package NDCs from labels
63323-340-21, 63323-340-20
Manufacturer
Fresenius Kabi USA, LLC | Antibióticos do Brasil Ltda
Effective date
2023-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefepime - Fresenius Kabi USA, LLC | Antibióticos do Brasil LtdaFresenius Kabi USA, LLC | Antibióticos do Brasil Ltda2023-09-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-340-20Cefepime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1011
63323-340-21Cefepime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-340CEFEPIME INJECTION, POWDER, FOR SOLUTION CEFEPIME (CEFEPIME) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]11Current NDC, Legacy NDC, 2 package rows20231014_5e1695e0-1310-4cd8-a5da-ad1a7dcd1792.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-340-20EA - Each63323-340669969ba-acd1-48bc-8ead-baf485cd7bf212012-07-24
63323-340-21EA - Each63323-340058935dc-50d4-42fb-9fe4-d1533914566f12019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFEPIME HYDROCHLORIDEACTIVE INGREDIENTI8X1O0607PCEFEPIME INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5
CEFEPIMEACTIVE MOIETY807PW4VQE3CEFEPIME INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5

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 1 of 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin Smoothing CareCENTELLA ASIATICA TRITERPENOIDSHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a77f521-2948-6c88-e063-6394a90ad18f2026-09-01WarningsExact identifier
unii: 94ZLA3W45F
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 94ZLA3W45F
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 94ZLA3W45F
CefepimeCEFEPIMEBaxter Healthcare Corporationbe5f8ca6-7232-423a-a2d5-cccb7abe79212026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 1665093
rxcui: 1665088
unii: I8X1O0607P
CefepimeCEFEPIMEWG Critical Care, LLC5fd857e5-591f-44ca-80cf-fd903660b03c2026-06-23Warnings, Adverse reactionsExact identifier
application number: ANDA065441
rxcui: 1665093
rxcui: 1665088
unii: I8X1O0607P
CefepimeCEFEPIMEWG Critical Care, LLCc654ef2e-1067-4026-8931-6a0dc2a17ad12026-06-23Warnings, Adverse reactionsExact identifier
application number: ANDA065441
rxcui: 1665093
rxcui: 1665088
unii: I8X1O0607P
ZAYNICHZIDEBACTAM DIHYDRATE AND CEFEPIME HYDROCHLORIDEWockhardt Suisse USA LLCc84e652e-5e76-4568-8812-bd5fa34803b62026-06-05Warnings, Adverse reactionsExact identifier
unii: I8X1O0607P
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDEB. Braun Medical Inc.57517a0e-ec1b-4605-a7cc-7e3801158ec92026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 1665093
rxcui: 1665088
unii: I8X1O0607P
BEE VENOM SKIN FIRMING CreamBEE VENOMGuangzhou Mizi Biotechnology Co., LTD.4ccf576f-b6bb-42ac-e063-6294a90a36522026-03-12WarningsExact identifier
unii: 94ZLA3W45F
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 94ZLA3W45F
Growth Hormone Drops 2160GROWTH HORMONE DROPSProfessional Complementary Health Formulas56536a40-febe-4856-8a74-ed96a7e5a5c32026-01-08WarningsExact identifier
unii: 94ZLA3W45F
L-Arginine 7401L-ARGININEProfessional Complementary Health Formulas07c10c55-5e96-4ec0-95cc-019fd0a4bca72026-01-08WarningsExact identifier
unii: 94ZLA3W45F
A-L-O Liquid Drops 2082A-L-O LIQUID DROPSProfessional Complementary Health Formulas65e081be-4fc6-416b-aacd-55b194b77b3b2026-01-08WarningsExact identifier
unii: 94ZLA3W45F
L-Arginine High 7402L-ARGININE HIGHProfessional Complementary Health Formulas5274a1f6-dfa2-452a-9077-0f66eee4e22b2026-01-08WarningsExact identifier
unii: 94ZLA3W45F
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 94ZLA3W45F
Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINEICU Medical Inc.5b426208-f090-4650-86c3-89040ba45c2d2025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.2d212e10-7e08-4aeb-b63f-dcc9278977692025-10-17Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
Cefepime HydrochlorideCEFEPIME HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b9914e7e-13f6-42d4-9cbb-8c7ed1ce7a012025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 1665093
rxcui: 1665088
unii: I8X1O0607P

Reported adverse events (FAERS/openFDA)#

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