phytonadione

Generic: phytonadione

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phytonadione 5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1581
Product ID 67046-1581_3e4f86c4-7e70-c864-e063-6394a90a59af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210189
Listing Expiration 2026-12-31
Marketing Start 2025-09-08

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 670461581
Hyphenated Format 67046-1581

Supplemental Identifiers

RxCUI
198102
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 ANDA210189 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1581-3)
source: ndc

Packages (1)

67046-1581-3 30 TABLET in 1 BLISTER PACK (67046-1581-3)

Ingredients (1)

phytonadione (5 mg/1)

Linked Drug Pages (1)

Phytonadione ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e4f86c4-7e70-c864-e063-6394a90a59af", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["198102"], "spl_set_id": ["3e4f86c4-7e89-c864-e063-6394a90a59af"], "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": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1581-3)", "package_ndc": "67046-1581-3", "marketing_start_date": "20250908"}], "brand_name": "Phytonadione", "product_id": "67046-1581_3e4f86c4-7e70-c864-e063-6394a90a59af", "dosage_form": "TABLET", "pharm_class": ["Increased Prothrombin Activity [PE]", "Reversed Anticoagulation Activity [PE]", "Vitamin K [CS]", "Vitamin K [EPC]", "Warfarin Reversal Agent [EPC]"], "product_ndc": "67046-1581", "generic_name": "Phytonadione", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "5 mg/1"}], "application_number": "ANDA210189", "marketing_category": "ANDA", "marketing_start_date": "20250908", "listing_expiration_date": "20261231"}