phytonadione

Generic: phytonadione

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

phytonadione 10 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-151
Product ID 65145-151_114b1330-6f03-476c-8678-8cd0da189bce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219212
Listing Expiration 2026-12-31
Marketing Start 2025-04-26

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 65145151
Hyphenated Format 65145-151

Supplemental Identifiers

RxCUI
1670192
UPC
0365145151100 0365145151056 0365145151018
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 ANDA219212 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 2 TRAY in 1 CARTON (65145-151-10) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65145-151-05) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-151-01)
source: ndc

Packages (1)

65145-151-10 2 TRAY in 1 CARTON (65145-151-10) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65145-151-05) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-151-01)

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": "114b1330-6f03-476c-8678-8cd0da189bce", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "upc": ["0365145151100", "0365145151056", "0365145151018"], "unii": ["A034SE7857"], "rxcui": ["1670192"], "spl_set_id": ["114b1330-6f03-476c-8678-8cd0da189bce"], "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": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 CARTON (65145-151-10)  / 5 VIAL, SINGLE-DOSE in 1 TRAY (65145-151-05)  / 1 mL in 1 VIAL, SINGLE-DOSE (65145-151-01)", "package_ndc": "65145-151-10", "marketing_start_date": "20250426"}], "brand_name": "Phytonadione", "product_id": "65145-151_114b1330-6f03-476c-8678-8cd0da189bce", "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": "65145-151", "generic_name": "Phytonadione", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "10 mg/mL"}], "application_number": "ANDA219212", "marketing_category": "ANDA", "marketing_start_date": "20250426", "listing_expiration_date": "20261231"}