phytonadione

Generic: phytonadione

Labeler: sciegen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler sciegen pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phytonadione 5 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-333
Product ID 50228-333_02ae977c-f584-4433-e063-6394a90a1290
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213329
Listing Expiration 2026-12-31
Marketing Start 2023-07-28

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 50228333
Hyphenated Format 50228-333

Supplemental Identifiers

RxCUI
198102
UPC
0350228333306 0350228333016
UNII
A034SE7857
NUI
N0000175965 N0000175982 M0022806 N0000180191 N0000175966

Packaging Origin

Original Packager
true

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 ANDA213329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50228-333-01) / 100 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50228-333-30) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (2)

50228-333-01 1 BOTTLE in 1 CARTON (50228-333-01) / 100 TABLET in 1 BOTTLE 50228-333-30 1 BOTTLE in 1 CARTON (50228-333-30) / 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": "02ae977c-f584-4433-e063-6394a90a1290", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "upc": ["0350228333306", "0350228333016"], "unii": ["A034SE7857"], "rxcui": ["198102"], "spl_set_id": ["c0e38a20-7225-46a5-9730-924cbd08dbee"], "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": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50228-333-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "50228-333-01", "marketing_start_date": "20230728"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50228-333-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "50228-333-30", "marketing_start_date": "20230728"}], "brand_name": "Phytonadione", "product_id": "50228-333_02ae977c-f584-4433-e063-6394a90a1290", "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": "50228-333", "generic_name": "Phytonadione", "labeler_name": "ScieGen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "5 mg/1"}], "application_number": "ANDA213329", "marketing_category": "ANDA", "marketing_start_date": "20230728", "listing_expiration_date": "20261231"}