FDA.reportPublic FDA data

NDC 0409-9158-50 - 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
0409-9158-50
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 1 of 20 · 382 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
PHYTONADIONEPHYTONADIONEHF Acquisition Co LLC, DBA HealthFirst5686f34b-446a-00ae-e063-6394a90a60292026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670192
unii: A034SE7857
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Vitamin K1PHYTONADIONEHospira, Inc.e8808230-2c44-44c6-8cab-8f29b6b340512026-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA087954
application number: ANDA087955
ndc (package): 0409-9157-31
ndc (package): 0409-9158-25
ndc (package): 0409-9158-01
ndc (package): 0409-9157-01
ndc (package): 0409-9158-11
ndc (package): 0409-9158-31
ndc (package): 0409-9158-50
ndc (package): 0409-9157-50
ndc (package): 0409-9158-55
ndc (product): 0409-9158
ndc (product): 0409-9157
ndc11 (package): 00409915850
rxcui: 312424
rxcui: 1670192
spl id: 689ec2ad-01a2-43bb-82f4-ac5cf0d91313
spl set id: e8808230-2c44-44c6-8cab-8f29b6b34051
unii: A034SE7857
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Infant DextroseDEXTROSEHenry Schein, Inc.ce71d929-d11e-444c-bd45-e025d51720572026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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