phytonadione

Generic: phytonadione

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

phytonadione 5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-566
Product ID 42291-566_487102e3-f317-836b-e063-6394a90a4438
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209373
Listing Expiration 2027-12-31
Marketing Start 2023-09-07

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 42291566
Hyphenated Format 42291-566

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 ANDA209373 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (42291-566-30) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

42291-566-30 1 BOTTLE in 1 BOX (42291-566-30) / 30 TABLET in 1 BOTTLE

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": "487102e3-f317-836b-e063-6394a90a4438", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["198102"], "spl_set_id": ["04c776dd-b60d-23f6-e063-6394a90a247c"], "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": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (42291-566-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "42291-566-30", "marketing_start_date": "20230907"}], "brand_name": "Phytonadione", "product_id": "42291-566_487102e3-f317-836b-e063-6394a90a4438", "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": "42291-566", "generic_name": "Phytonadione", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "5 mg/1"}], "application_number": "ANDA209373", "marketing_category": "ANDA", "marketing_start_date": "20230907", "listing_expiration_date": "20271231"}