phytonadione

Generic: phytonadione

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler gland pharma limited
Dosage Form INJECTION, EMULSION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

phytonadione 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-606
Product ID 68083-606_1d345aaf-a506-4d73-a0ac-41c41675cebf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217386
Listing Expiration 2026-12-31
Marketing Start 2024-12-10

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 68083606
Hyphenated Format 68083-606

Supplemental Identifiers

RxCUI
1670192
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 ANDA217386 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 TRAY in 1 CARTON (68083-606-25) / 5 AMPULE in 1 TRAY (68083-606-05) / 1 mL in 1 AMPULE
source: ndc

Packages (1)

68083-606-25 5 TRAY in 1 CARTON (68083-606-25) / 5 AMPULE in 1 TRAY (68083-606-05) / 1 mL in 1 AMPULE

Ingredients (1)

phytonadione (10 mg/mL)

Linked Drug Pages (1)

Phytonadione ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "1d345aaf-a506-4d73-a0ac-41c41675cebf", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["1670192"], "spl_set_id": ["c375bfab-5a4b-40f3-a783-8372158af860"], "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": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 TRAY in 1 CARTON (68083-606-25)  / 5 AMPULE in 1 TRAY (68083-606-05)  / 1 mL in 1 AMPULE", "package_ndc": "68083-606-25", "marketing_start_date": "20241210"}], "brand_name": "Phytonadione", "product_id": "68083-606_1d345aaf-a506-4d73-a0ac-41c41675cebf", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["Increased Prothrombin Activity [PE]", "Reversed Anticoagulation Activity [PE]", "Vitamin K [CS]", "Vitamin K [EPC]", "Warfarin Reversal Agent [EPC]"], "product_ndc": "68083-606", "generic_name": "Phytonadione", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "10 mg/mL"}], "application_number": "ANDA217386", "marketing_category": "ANDA", "marketing_start_date": "20241210", "listing_expiration_date": "20261231"}