phytonadione phytonadione

Generic: phytonadione

Labeler: dr.reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phytonadione phytonadione
Generic Name phytonadione
Labeler dr.reddy's laboratories inc
Dosage Form INJECTION, EMULSION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

phytonadione 10 mg/mL

Manufacturer
Dr.Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-405
Product ID 43598-405_c4a2bf44-0ad2-c0d2-164f-562ba6df930c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207719
Listing Expiration 2026-12-31
Marketing Start 2019-05-31

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 43598405
Hyphenated Format 43598-405

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 phytonadione (source: ndc)
Generic Name phytonadione (source: ndc)
Application Number ANDA207719 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11)
source: ndc

Packages (1)

43598-405-16 25 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11)

Ingredients (1)

phytonadione (10 mg/mL)

Linked Drug Pages (1)

PHYTONADIONE PHYTONADIONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "c4a2bf44-0ad2-c0d2-164f-562ba6df930c", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["1670192"], "spl_set_id": ["02445c07-7b4b-cd70-54e8-ebefc814f547"], "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": ["Dr.Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 AMPULE in 1 CARTON (43598-405-16)  / 1 mL in 1 AMPULE (43598-405-11)", "package_ndc": "43598-405-16", "marketing_start_date": "20190531"}], "brand_name": "PHYTONADIONE PHYTONADIONE", "product_id": "43598-405_c4a2bf44-0ad2-c0d2-164f-562ba6df930c", "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": "43598-405", "generic_name": "PHYTONADIONE", "labeler_name": "Dr.Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHYTONADIONE", "brand_name_suffix": "PHYTONADIONE", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "10 mg/mL"}], "application_number": "ANDA207719", "marketing_category": "ANDA", "marketing_start_date": "20190531", "listing_expiration_date": "20261231"}