phytonadione

Generic: phytonadione

Labeler: agnitio inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler agnitio inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phytonadione 5 mg/1

Manufacturer
Agnitio Inc.

Identifiers & Regulatory

Product NDC 72134-008
Product ID 72134-008_efc664b8-931d-4577-8b06-9653637eb89a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213336
Listing Expiration 2026-12-31
Marketing Start 2022-02-11

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 72134008
Hyphenated Format 72134-008

Supplemental Identifiers

RxCUI
198102
UPC
0372134008017 0372134003012
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 ANDA213336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72134-008-01)
source: ndc

Packages (1)

72134-008-01 100 TABLET in 1 BOTTLE (72134-008-01)

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": "efc664b8-931d-4577-8b06-9653637eb89a", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "upc": ["0372134008017", "0372134003012"], "unii": ["A034SE7857"], "rxcui": ["198102"], "spl_set_id": ["66ada4f8-c5a9-49f1-848f-e172416892a1"], "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": ["Agnitio Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72134-008-01)", "package_ndc": "72134-008-01", "marketing_start_date": "20220211"}], "brand_name": "Phytonadione", "product_id": "72134-008_efc664b8-931d-4577-8b06-9653637eb89a", "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": "72134-008", "generic_name": "Phytonadione", "labeler_name": "Agnitio Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "5 mg/1"}], "application_number": "ANDA213336", "marketing_category": "ANDA", "marketing_start_date": "20220211", "listing_expiration_date": "20261231"}