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 10 mg/mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-708
Product ID 69097-708_b3dd9cac-1295-48b6-b9b1-48d36cb732b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214596
Listing Expiration 2026-12-31
Marketing Start 2022-04-27

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 69097708
Hyphenated Format 69097-708

Supplemental Identifiers

RxCUI
312424 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 ANDA214596 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (69097-708-96) / 1 mL in 1 VIAL
source: ndc

Packages (1)

69097-708-96 10 VIAL in 1 CARTON (69097-708-96) / 1 mL in 1 VIAL

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": "b3dd9cac-1295-48b6-b9b1-48d36cb732b9", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["312424", "1670192"], "spl_set_id": ["1add4de5-0f9c-453e-9dd5-abb8077b566a"], "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 VIAL in 1 CARTON (69097-708-96)  / 1 mL in 1 VIAL", "package_ndc": "69097-708-96", "marketing_start_date": "20220427"}], "brand_name": "Phytonadione", "product_id": "69097-708_b3dd9cac-1295-48b6-b9b1-48d36cb732b9", "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": "69097-708", "generic_name": "Phytonadione", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "10 mg/mL"}], "application_number": "ANDA214596", "marketing_category": "ANDA", "marketing_start_date": "20220427", "listing_expiration_date": "20261231"}