phytonadione

Generic: phytonadione

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, EMULSION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

phytonadione 1 mg/.5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1682
Product ID 70121-1682_a2f87d42-33cd-4706-bd3c-8b15c8095617
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216601
Listing Expiration 2026-12-31
Marketing Start 2025-11-04

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 701211682
Hyphenated Format 70121-1682

Supplemental Identifiers

RxCUI
727625
UPC
0370121168218
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 ANDA216601 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/.5mL
source: ndc
Packaging
  • 10 TRAY in 1 CARTON (70121-1682-7) / 1 SYRINGE, GLASS in 1 TRAY (70121-1682-1) / .5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

70121-1682-7 10 TRAY in 1 CARTON (70121-1682-7) / 1 SYRINGE, GLASS in 1 TRAY (70121-1682-1) / .5 mL in 1 SYRINGE, GLASS

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": "a2f87d42-33cd-4706-bd3c-8b15c8095617", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "upc": ["0370121168218"], "unii": ["A034SE7857"], "rxcui": ["727625"], "spl_set_id": ["2ce1dd90-11ad-4f74-af16-45b7e59f05da"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CARTON (70121-1682-7)  / 1 SYRINGE, GLASS in 1 TRAY (70121-1682-1)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "70121-1682-7", "marketing_start_date": "20251104"}], "brand_name": "phytonadione", "product_id": "70121-1682_a2f87d42-33cd-4706-bd3c-8b15c8095617", "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": "70121-1682", "generic_name": "PHYTONADIONE", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "1 mg/.5mL"}], "application_number": "ANDA216601", "marketing_category": "ANDA", "marketing_start_date": "20251104", "listing_expiration_date": "20261231"}