vitamin k1

Generic: phytonadione

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vitamin k1
Generic Name phytonadione
Labeler hospira, inc.
Dosage Form INJECTION, EMULSION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

phytonadione 2 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-9157
Product ID 0409-9157_376c06f4-4a3b-4114-a46e-1742d3f7ea82
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087954
Listing Expiration 2026-12-31
Marketing Start 2005-06-22

Pharmacologic Class

Established (EPC)
vitamin k [epc] warfarin reversal agent [epc]
Chemical Structure
vitamin k [cs]
Physiologic Effect
increased prothrombin activity [pe] reversed anticoagulation activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04099157
Hyphenated Format 0409-9157

Supplemental Identifiers

RxCUI
312424 1670192
UNII
A034SE7857
NUI
N0000175965 N0000175982 M0022806 N0000180191 N0000175966

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vitamin k1 (source: ndc)
Generic Name phytonadione (source: ndc)
Application Number ANDA087954 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 5 TRAY in 1 CONTAINER (0409-9157-01) / 5 AMPULE in 1 TRAY (0409-9157-50) / .5 mL in 1 AMPULE (0409-9157-31)
source: ndc

Packages (1)

0409-9157-01 5 TRAY in 1 CONTAINER (0409-9157-01) / 5 AMPULE in 1 TRAY (0409-9157-50) / .5 mL in 1 AMPULE (0409-9157-31)

Ingredients (1)

phytonadione (2 mg/mL)

Linked Drug Pages (1)

Vitamin K1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "376c06f4-4a3b-4114-a46e-1742d3f7ea82", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["312424", "1670192"], "spl_set_id": ["e8808230-2c44-44c6-8cab-8f29b6b34051"], "pharm_class_cs": ["Vitamin K [CS]"], "pharm_class_pe": ["Increased Prothrombin Activity [PE]", "Reversed Anticoagulation Activity [PE]"], "pharm_class_epc": ["Vitamin K [EPC]", "Warfarin Reversal Agent [EPC]"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 TRAY in 1 CONTAINER (0409-9157-01)  / 5 AMPULE in 1 TRAY (0409-9157-50)  / .5 mL in 1 AMPULE (0409-9157-31)", "package_ndc": "0409-9157-01", "marketing_start_date": "20050622"}], "brand_name": "Vitamin K1", "product_id": "0409-9157_376c06f4-4a3b-4114-a46e-1742d3f7ea82", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["Increased Prothrombin Activity [PE]", "Reversed Anticoagulation Activity [PE]", "Vitamin K [CS]", "Vitamin K [EPC]", "Warfarin Reversal Agent [EPC]"], "product_ndc": "0409-9157", "generic_name": "PHYTONADIONE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vitamin K1", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "2 mg/mL"}], "application_number": "ANDA087954", "marketing_category": "ANDA", "marketing_start_date": "20050622", "listing_expiration_date": "20261231"}