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 6 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
PHYTONADIONEPHYTONADIONEHenry Schein, Inc.1cf90be3-a744-4db5-999d-a84c673723042025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670192
unii: A034SE7857
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PHYTONADIONEPHYTONADIONEHenry Schein, Inc.0d971993-466c-46dd-bdd6-2e300173621e2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A034SE7857
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEICU Medical Inc.d8ee14e9-6733-4813-9f21-2b043a5f71882025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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