vitamin k1 phytonadione

Generic: vitamin k1, phytonadione

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 2 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1537
Product ID 51662-1537_1034dbd2-6cd0-dd97-e063-6294a90a19b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087954
Listing Expiration 2026-12-31
Marketing Start 2021-11-01

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 516621537
Hyphenated Format 51662-1537

Supplemental Identifiers

RxCUI
312424
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 ANDA087954 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 POUCH in 1 BOX (51662-1537-3) / 1 AMPULE in 1 POUCH (51662-1537-2) / .5 mL in 1 AMPULE
source: ndc

Packages (1)

51662-1537-3 25 POUCH in 1 BOX (51662-1537-3) / 1 AMPULE in 1 POUCH (51662-1537-2) / .5 mL in 1 AMPULE

Ingredients (1)

phytonadione (2 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": "1034dbd2-6cd0-dd97-e063-6294a90a19b1", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["312424"], "spl_set_id": ["cfc0df9f-ee59-9e30-e053-2995a90ad449"], "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 (51662-1537-3)  / 1 AMPULE in 1 POUCH (51662-1537-2)  / .5 mL in 1 AMPULE", "package_ndc": "51662-1537-3", "marketing_start_date": "20211101"}], "brand_name": "VITAMIN K1 PHYTONADIONE", "product_id": "51662-1537_1034dbd2-6cd0-dd97-e063-6294a90a19b1", "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": "51662-1537", "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": "2 mg/mL"}], "application_number": "ANDA087954", "marketing_category": "ANDA", "marketing_start_date": "20211101", "listing_expiration_date": "20261231"}