FDA.reportPublic FDA data

NDC 0409-9158-55 - Vitamin K1

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
0409-9158
Requested NDC
0409-9158-55
Package NDCs from labels
0409-9158-31, 0409-9158-50, 0409-9158-01, 0409-9158-11, 0409-9158-55, 0409-9158-25
Manufacturer
Hospira, Inc.
Effective date
2026-08-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vitamin K1 - Hospira, Inc.Hospira, Inc.2026-08-09HUMAN PRESCRIPTION DRUG LABEL
VITAMIN K1 - PHYTONADIONE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-30HUMAN PRESCRIPTION DRUG LABEL
Vitamin K1 - A-S Medication SolutionsA-S Medication Solutions2021-06-14HUMAN PRESCRIPTION DRUG LABEL
Vitamin K1 - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2019-09-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-9158-01Vitamin K15 in 1 CONTAINERINJECTION, EMULSION522
0409-9158-11Vitamin K11 mL in 1 AMPULEINJECTION, EMULSION122
0409-9158-25Vitamin K15 in 1 CONTAINERINJECTION, EMULSION522
0409-9158-31Vitamin K11 mL in 1 AMPULEINJECTION, EMULSION122
0409-9158-50Vitamin K15 in 1 TRAYINJECTION, EMULSION522
0409-9158-55Vitamin K15 in 1 TRAYINJECTION, EMULSION522

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-9158VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]20Current NDC, Legacy NDC, 6 package rows20241207_e8808230-2c44-44c6-8cab-8f29b6b34051.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9158-01ML - Milliliter0409-91588fb330d1-d404-4a78-acfd-5df697a9e0ed12012-07-24
0409-9158-11ML - Milliliter0409-91580146bc02-99f6-4ebe-a841-7efdf09f67dd12021-02-05
0409-9158-25ML - Milliliter0409-91589d751c42-e63b-4531-8311-b1ca698b07c912014-06-03
0409-9158-31ML - Milliliter0409-91589210626c-ca6b-4eb6-8838-e7aaf567167a12019-08-06
0409-9158-50ML - Milliliter0409-9158d79e15d2-250f-4ed6-a41f-eaeb180b849312019-08-06
0409-9158-55ML - Milliliter0409-9158ecccb6dd-8e29-4af1-88ae-a857682144b112021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHYTONADIONEACTIVE INGREDIENTA034SE7857VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]12
PHYTONADIONEACTIVE MOIETYA034SE7857VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]12
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHVITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]12
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GVITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]12
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OVITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RVITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]12
PhytonadioneACTIVE INGREDIENTA034SE7857VITAMIN K1 (PHYTONADIONE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
PhytonadioneACTIVE MOIETYA034SE7857VITAMIN K1 (PHYTONADIONE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]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 5 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: LX22YL083G
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: LX22YL083G
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: LX22YL083G
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
PhytonadionePHYTONADIONEGLENMARK PHARMACEUTICALS INC60e5abd1-e2fa-4a5e-b25b-3ec6cfdeed142025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670192
unii: A034SE7857
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: LX22YL083G
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
PhytonadionePHYTONADIONEAgnitio Inc.66ada4f8-c5a9-49f1-848f-e172416892a12025-12-01Adverse reactionsExact identifier
unii: A034SE7857
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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