FDA.reportPublic FDA data

NDC 63323-402-01 - Aztreonam

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
63323-402
Requested NDC
63323-402-01
Package NDCs from labels
63323-402-41, 63323-402-24, 63323-402-03, 63323-402-30, 63323-402-01, 63323-402-20
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2022-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aztreonam - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-05-06HUMAN PRESCRIPTION DRUG LABEL
Aztreonam - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-04-30HUMAN PRESCRIPTION DRUG LABEL
Aztreonam - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-03-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-402-01Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,19
63323-402-20Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,109
63323-402-24Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,106
63323-402-41Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,16
63323-402-03Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14
63323-402-30Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-402AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 2 package rows20220412_c6cf7e13-a04e-47e2-9cec-44a278ee6bec.zip
63323-402AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20220604_5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18.zip
63323-402AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20220602_302fd27d-0a22-44ea-91fb-1b1ffcf17a1f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-402-01EA - Each63323-402b23a6f85-5a3f-4639-931d-27d3d8cd43cf12021-10-08
63323-402-03EA - Each63323-402829e5b27-333e-427f-919f-4d835ae77d4612022-02-07
63323-402-20EA - Each63323-40211dc9e32-70b9-47f0-a852-8186ac23864212012-07-24
63323-402-24EA - Each63323-40236267525-0323-4e58-baf3-e73179fae05912014-09-03
63323-402-30EA - Each63323-4029d05de5c-f22e-4c17-a1ca-658b3027f56f12015-06-09
63323-402-41EA - Each63323-402ee9a0d12-2968-41dd-87cf-6602206419fb12022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZTREONAMACTIVE INGREDIENTG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
AZTREONAMACTIVE MOIETYG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
ARGININEINACTIVE INGREDIENT94ZLA3W45FAZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
AZTREONAMACTIVE INGREDIENTG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
AZTREONAMACTIVE MOIETYG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
ARGININEINACTIVE INGREDIENT94ZLA3W45FAZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
AZTREONAMACTIVE INGREDIENTG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
AZTREONAMACTIVE MOIETYG2B4VE5GH8AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FAZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: 94ZLA3W45F
Adrenal and DHEAARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.ProBLEN44991952-c440-4a33-9423-a9369c8bab702021-10-22WarningsExact identifier
unii: 94ZLA3W45F
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
CLINIMIXLEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSEBaxter Healthcare Corporationdccff103-8695-400c-a15d-cc2fd078760a2021-04-13Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
TOTAL PRO-JESADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONEWhite Manufacturing Inc. BDA Micro-Westb26953f8-7b56-432c-958c-d80c528fbb6a2021-01-21WarningsExact identifier
unii: 94ZLA3W45F
TravasolLEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINEBaxter Healthcare Corporation8543b5be-0f43-4891-9e56-d7c39fe839b52020-10-07Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F

Reported adverse events (FAERS/openFDA)#

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