FDA.reportPublic FDA data

NDC 63323-401-01 - 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
63323-401
Requested NDC
63323-401-01
Package NDCs from labels
63323-401-41, 63323-401-24, 63323-401-21, 63323-401-26, 63323-401-01, 63323-401-20
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
63323-401-01Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,19
63323-401-20Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,109
63323-401-24Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,106
63323-401-41Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,16
63323-401-21Aztreonam1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14
63323-401-26Aztreonam10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-401AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 2 package rows20220412_c6cf7e13-a04e-47e2-9cec-44a278ee6bec.zip
63323-401AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20220604_5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18.zip
63323-401AZTREONAM (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
63323-401-01EA - Each63323-401a9386f71-2a19-4f1b-a550-feee3dea552212022-04-06
63323-401-20EA - Each63323-401a71b0183-505c-41a9-ac62-0fee3e4ac51e12012-07-24
63323-401-21EA - Each63323-401cba85672-d36e-4f89-b42c-bb91916b593112023-04-07
63323-401-24EA - Each63323-40142869732-d570-49f8-9692-dcc2e4ed562812014-09-03
63323-401-26EA - Each63323-401e2b013d2-0070-4bbf-ba9f-90f82821001e12015-06-09
63323-401-41EA - Each63323-40141e4c816-e06b-4051-a14c-9d1ca83e353d12022-07-06

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 2 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: 94ZLA3W45F
D-87PHYTOLACCA AMERICANA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, FUCUS VESICULOSUS, THYROID, UNSPECIFIED, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARGININE, TYROSINE, AND NIACINDNA Labs, Inc.198c61a4-780e-4651-9a92-f629a86fead62025-01-13WarningsExact identifier
unii: 94ZLA3W45F
N-17ZINC, SELENIUM, BOS TAURUS THYMUS, SUS SCROFA SPLEEN, BOS TAURUS LYMPH, BOS TAURUS ADRENAL GLAND, ARGININE, CYSTINE, ECHINACEA ANGUSTIFOLIA, THIAMINE, PYRIDOXINE HYDROCHLORIDE, AND ASCORBIC ACIDDNA Labs, Inc.a6a13048-b1b4-4a46-acad-d379d4e4b6fb2025-01-09WarningsExact identifier
unii: 94ZLA3W45F
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 94ZLA3W45F
AZACTAMAZTREONAMA-S Medication Solutionsf9d5515e-54bc-4efc-9f49-8ee3e88c3e012025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 1664981
unii: G2B4VE5GH8
Strength FALPHA-KETOGLUTARICUM ACIDUM, ISOLEUCINE, L-ARGININE, L CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, ESTRADIOL, FOLLICULINUM, PROGESTERONE, TESTOSTERONE, OOPHORINUM (SUIS)BioActive Nutritional, Inc.a4f3a8e7-0a28-4aa0-ba0c-201807d62c962025-01-03WarningsExact identifier
unii: 94ZLA3W45F
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: 94ZLA3W45F
Strength MARALIA QUINQUEFOLIA, AVENA SATIVA, DAMIANA, EPIMEDIUM GRANDIFLORUM, GLUTATHIONE, L-ARGININE, L-LEUCINE, L-ORNITHINE, L-VALINE, TESTOSTERONE, SABAL SERRULATA, SEPIABioActive Nutritional, Inc.8eda49aa-da6c-4e06-926c-73f35f33e5d82024-10-18WarningsExact identifier
unii: 94ZLA3W45F
VITAL IIARNICA MONTANA, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYPOPHYSIS SUIS, PANAX GINSENG, L-ARGININE, OLEUM ANIMALE, SCHISANDRA CHINENSIS, TARAXACUM OFFICINALE, THUJA OCCIDENTALISLiddell Laboratories, Inc.04cded9a-0431-4e87-9055-ec4f381125592024-07-01WarningsExact identifier
unii: 94ZLA3W45F
AztreonamAZTREONAMHospira, Inc.d4500795-3b07-4a7d-b432-73cafbb3dbc62024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 1664981
rxcui: 1664986
unii: G2B4VE5GH8
VascuflowMELATONIN, L-ARGININE, L-CITRULLINE, UBIDECARENONUM, SQUALENE, CALCAREA CARBONICA, CHOLESTERINUM, COUMARINUM, FORMALINUM, GELSEMIUM SEMPERVIRENS, ALPHA-LIPOICUM ACIDUM, MERCURIUS CORROSIVUS, PLUMBUM METALLICUM, PANTOTHENIC ACID, GLONOINUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, BERBERIS VULGARIS, RED YEAST RICE, NITRIC OXIDE, PROTEUS (MORGANI), RHUS TOXDeseret Biologicals, Inc.1ca5d57d-7cf0-4b9a-afa0-767dca99864d2024-04-02WarningsExact identifier
unii: 94ZLA3W45F
Dr Dale Wellness NU Fem 1 2 3 All In One Topical HomeopathicDHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSADMD Clinical Naturopathy7679472c-bc6a-40c1-8e66-adc0b6ca18b42024-03-21WarningsExact identifier
unii: 94ZLA3W45F
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 94ZLA3W45F
A L O FormulaCHOLINUM, L-ARGININE, L-CARNITINE, L-ORNITHINE, PANTOTHENIC ACIDNutritional Specialties, Inc.0df7e08c-c17f-4e5e-acfd-05f8af7277cc2023-07-07WarningsExact identifier
unii: 94ZLA3W45F
Vital Skin Hair NailsL-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, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.3e8a9233-6e65-4023-b3f8-8bca369a9c2a2023-06-15WarningsExact identifier
unii: 94ZLA3W45F
CellTropinARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUSMicro Balance Health Products LLC502d3ffa-bbf4-403a-9fad-b6b229f36a8c2023-02-14WarningsExact identifier
unii: 94ZLA3W45F
Premasol - sulfite-free (Amino Acid)LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDEBaxter Healthcare Company9afdcc3e-0d06-47f4-86ca-40da48b2b02b2022-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
AztreonamAZTREONAMFresenius Kabi USA, LLC5f5ebb63-6ac5-4fb4-bcc1-d069c123eb182022-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA065439
ndc (package): 63323-402-24
ndc (package): 63323-401-24
ndc (package): 63323-401-41
ndc (package): 63323-402-41
ndc (product): 63323-401
ndc (product): 63323-402
rxcui: 1664981
rxcui: 1664986
spl id: 8fe750bd-6416-428f-9184-7b15c7fe9d45
spl set id: 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18
unii: G2B4VE5GH8
AztreonamAZTREONAMFresenius Kabi USA, LLC302fd27d-0a22-44ea-91fb-1b1ffcf17a1f2022-04-30Warnings, Adverse reactionsExact identifier
application number: ANDA065439
ndc (package): 63323-402-03
ndc (package): 63323-401-21
ndc (package): 63323-401-26
ndc (package): 63323-402-30
ndc (product): 63323-401
ndc (product): 63323-402
rxcui: 1664981
rxcui: 1664986
spl id: 6cd42e51-1a5d-4c6a-8881-0cbde3ca8d70
spl set id: 302fd27d-0a22-44ea-91fb-1b1ffcf17a1f
unii: G2B4VE5GH8
AztreonamAZTREONAMFresenius Kabi USA, LLCc6cf7e13-a04e-47e2-9cec-44a278ee6bec2022-03-29Warnings, Adverse reactionsExact identifier
application number: ANDA065439
ndc (package): 63323-402-20
ndc (package): 63323-401-20
ndc (package): 63323-402-01
ndc (package): 63323-401-01
ndc (product): 63323-401
ndc (product): 63323-402
ndc11 (package): 63323040101
rxcui: 1664981
rxcui: 1664986
spl id: b6926b10-085f-4255-b4f1-24572a7ef57a
spl set id: c6cf7e13-a04e-47e2-9cec-44a278ee6bec
unii: G2B4VE5GH8

Reported adverse events (FAERS/openFDA)#

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