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 9 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: LX22YL083G
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation36e9478c-5df0-4b47-b97d-de3626d7cb292025-06-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC67bee807-7ba8-4e92-81f2-c888118d277e2025-05-09Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0fb30b7e-8e1b-49c7-afac-2d5c01b9ff452025-05-09Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb0f2c9a2-d9d4-4907-a324-e7a26d489f442025-05-09Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCa829d4eb-3ec5-453c-b270-793969af15b32025-05-09Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC50fc30a0-0eca-452e-825e-08c2647ccfc12025-05-08Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb2b780d3-26ac-4e7c-a0f2-78991bee32a82025-05-07Exact identifier
unii: LX22YL083G
PhytonadionePHYTONADIONECaplin Steriles Limited114b1330-6f03-476c-8678-8cd0da189bce2025-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670192
unii: A034SE7857
PhytonadionePHYTONADIONEFresenius Kabi USA, LLC02a39690-38e6-42e9-9897-391c2df9e07e2025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670192
unii: A034SE7857
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: LX22YL083G
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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