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 3 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VITAMIN K1 PHYTONADIONEVITAMIN K1, PHYTONADIONEHF Acquisition Co LLC, DBA HealthFirstcfc0df9f-ee59-9e30-e053-2995a90ad4492026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA087954
rxcui: 312424
unii: A034SE7857
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEHospira, Inc.10e98cb0-31a5-4ad1-3eaa-aa4af387a42d2026-06-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
DextroseDEXTROSEB. Braun Medical Inc.60b6d7c3-0164-46c9-aa38-b5aa1c31a5d52026-05-12Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: LKG8494WBH
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
PHYTONADIONEPHYTONADIONESun Pharmaceutical Industries, Inc.51c175dd-02f9-68d1-e063-6294a90a4b362026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A034SE7857
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.40fd1ac4-39bb-45fb-ba99-4fb65481f2312026-04-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
PHYTONADIONEPHYTONADIONEAmneal Pharmaceuticals Private Limitedddd351d3-8b9e-482d-9ab8-f367ce1c3cc02026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670192
unii: A034SE7857
PHYTONADIONEPHYTONADIONEOrbicular Pharmaceutical Technologies Private Limitedd954e3d7-a4d5-4798-887d-7af916ff01812026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A034SE7857
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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