phytonadione

Generic: phytonadione

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

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler henry schein, inc.
Dosage Form INJECTION, EMULSION
Routes
PARENTERAL
Active Ingredients

phytonadione 1 mg/.5mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9935
Product ID 0404-9935_d8f4e356-c09c-4efe-961a-98a96174b73f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083722
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

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 04049935
Hyphenated Format 0404-9935

Supplemental Identifiers

RxCUI
727625
UNII
A034SE7857
NUI
N0000175965 N0000175982 M0022806 N0000180191 N0000175966

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 phytonadione (source: ndc)
Generic Name phytonadione (source: ndc)
Application Number ANDA083722 (source: ndc)
Routes
PARENTERAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/.5mL
source: ndc
Packaging
  • 1 BOX in 1 BAG (0404-9935-05) / 1 SYRINGE in 1 BOX / .5 mL in 1 SYRINGE
source: ndc

Packages (1)

0404-9935-05 1 BOX in 1 BAG (0404-9935-05) / 1 SYRINGE in 1 BOX / .5 mL in 1 SYRINGE

Ingredients (1)

phytonadione (1 mg/.5mL)

Linked Drug Pages (1)

PHYTONADIONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["PARENTERAL"], "spl_id": "d8f4e356-c09c-4efe-961a-98a96174b73f", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["727625"], "spl_set_id": ["0d971993-466c-46dd-bdd6-2e300173621e"], "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": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOX in 1 BAG (0404-9935-05)  / 1 SYRINGE in 1 BOX / .5 mL in 1 SYRINGE", "package_ndc": "0404-9935-05", "marketing_start_date": "20220113"}], "brand_name": "PHYTONADIONE", "product_id": "0404-9935_d8f4e356-c09c-4efe-961a-98a96174b73f", "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": "0404-9935", "generic_name": "phytonadione", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHYTONADIONE", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "1 mg/.5mL"}], "application_number": "ANDA083722", "marketing_category": "ANDA", "marketing_start_date": "20220113", "listing_expiration_date": "20261231"}