vitamin k1 - phytonadione (51662-1536)

Drug Facts

Product Profile

Brand Name vitamin k1 - phytonadione

Generic Name vitamin k1 - phytonadione

Labeler hf acquisition co llc, dba healthfirst

Dosage Form INJECTION, EMULSION

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

Active Ingredients

phytonadione 10 mg/mL

Manufacturer

HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1536

Product ID 51662-1536_1034ddca-fc35-505d-e063-6394a90a92c3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA087955

Listing Expiration 2026-12-31

Marketing Start 2021-05-10

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 516621536

Hyphenated Format 51662-1536

Supplemental Identifiers

RxCUI

1670192

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 vitamin k1 - phytonadione (source: ndc)

Generic Name vitamin k1 - phytonadione (source: ndc)

Application Number ANDA087955 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

25 POUCH in 1 BOX (51662-1536-3) / 1 AMPULE in 1 POUCH (51662-1536-2) / 1 mL in 1 AMPULE

source: ndc

Packages (1)

51662-1536-3 25 POUCH in 1 BOX (51662-1536-3) / 1 AMPULE in 1 POUCH (51662-1536-2) / 1 mL in 1 AMPULE

Ingredients (1)

phytonadione (10 mg/mL)

Linked Drug Pages (1)

VITAMIN K1 - PHYTONADIONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "1034ddca-fc35-505d-e063-6394a90a92c3", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["1670192"], "spl_set_id": ["c204c720-88d3-a6d6-e053-2a95a90a3de5"], "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": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 BOX (51662-1536-3)  / 1 AMPULE in 1 POUCH (51662-1536-2)  / 1 mL in 1 AMPULE", "package_ndc": "51662-1536-3", "marketing_start_date": "20210510"}], "brand_name": "VITAMIN K1 - PHYTONADIONE", "product_id": "51662-1536_1034ddca-fc35-505d-e063-6394a90a92c3", "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": "51662-1536", "generic_name": "VITAMIN K1 - PHYTONADIONE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VITAMIN K1 - PHYTONADIONE", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "10 mg/mL"}], "application_number": "ANDA087955", "marketing_category": "ANDA", "marketing_start_date": "20210510", "listing_expiration_date": "20261231"}