phytonadione

Generic: phytonadione

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler exelan pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phytonadione 5 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-740
Product ID 76282-740_1c09ec9b-5913-42d4-92e2-34d26682556a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213329
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

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 76282740
Hyphenated Format 76282-740

Supplemental Identifiers

RxCUI
198102
UPC
0376282740300
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 (76282-740-30) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

76282-740-30 1 BOTTLE in 1 CARTON (76282-740-30) / 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": "1c09ec9b-5913-42d4-92e2-34d26682556a", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "upc": ["0376282740300"], "unii": ["A034SE7857"], "rxcui": ["198102"], "spl_set_id": ["63771c95-d4f5-42eb-b591-4df146f18cb0"], "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": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76282-740-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "76282-740-30", "marketing_start_date": "20231201"}], "brand_name": "Phytonadione", "product_id": "76282-740_1c09ec9b-5913-42d4-92e2-34d26682556a", "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": "76282-740", "generic_name": "Phytonadione", "labeler_name": "Exelan 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": "20231201", "listing_expiration_date": "20261231"}