phytonadione

Generic: phytonadione

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

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler cipla usa inc.
Dosage Form INJECTION, EMULSION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

phytonadione 1 mg/.5mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-003
Product ID 69097-003_d0d625e2-d304-4382-bd6a-e714de668f13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214966
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

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 69097003
Hyphenated Format 69097-003

Supplemental Identifiers

RxCUI
727625
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 ANDA214966 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/.5mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (69097-003-96) / .5 mL in 1 SYRINGE (69097-003-67)
source: ndc

Packages (1)

69097-003-96 10 SYRINGE in 1 CARTON (69097-003-96) / .5 mL in 1 SYRINGE (69097-003-67)

Ingredients (1)

phytonadione (1 mg/.5mL)

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": "d0d625e2-d304-4382-bd6a-e714de668f13", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["727625"], "spl_set_id": ["4bc2de7b-6564-4d77-8a65-6be57b706093"], "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": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (69097-003-96)  / .5 mL in 1 SYRINGE (69097-003-67)", "package_ndc": "69097-003-96", "marketing_start_date": "20250115"}], "brand_name": "Phytonadione", "product_id": "69097-003_d0d625e2-d304-4382-bd6a-e714de668f13", "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": "69097-003", "generic_name": "Phytonadione", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "1 mg/.5mL"}], "application_number": "ANDA214966", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}