phytonadione

Generic: phytonadione

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phytonadione
Generic Name phytonadione
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phytonadione 5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1318
Product ID 70771-1318_40070531-4723-48f2-89b4-9efde4d1c71f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210189
Listing Expiration 2026-12-31
Marketing Start 2019-02-22

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 707711318
Hyphenated Format 70771-1318

Supplemental Identifiers

RxCUI
198102
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 ANDA210189 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70771-1318-1) / 100 TABLET in 1 BOTTLE
  • 30 TABLET in 1 BOTTLE (70771-1318-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1318-4) / 10 TABLET in 1 BLISTER PACK (70771-1318-2)
source: ndc

Packages (3)

70771-1318-1 1 BOTTLE in 1 CARTON (70771-1318-1) / 100 TABLET in 1 BOTTLE 70771-1318-3 30 TABLET in 1 BOTTLE (70771-1318-3) 70771-1318-4 10 BLISTER PACK in 1 CARTON (70771-1318-4) / 10 TABLET in 1 BLISTER PACK (70771-1318-2)

Ingredients (1)

phytonadione (5 mg/1)

Linked Drug Pages (1)

Phytonadione ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40070531-4723-48f2-89b4-9efde4d1c71f", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["198102"], "spl_set_id": ["fa26f747-c64e-4090-a0cf-de3d3d9b004c"], "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": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70771-1318-1)  / 100 TABLET in 1 BOTTLE", "package_ndc": "70771-1318-1", "marketing_start_date": "20190222"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1318-3)", "package_ndc": "70771-1318-3", "marketing_start_date": "20211101"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1318-4)  / 10 TABLET in 1 BLISTER PACK (70771-1318-2)", "package_ndc": "70771-1318-4", "marketing_start_date": "20190222"}], "brand_name": "Phytonadione", "product_id": "70771-1318_40070531-4723-48f2-89b4-9efde4d1c71f", "dosage_form": "TABLET", "pharm_class": ["Increased Prothrombin Activity [PE]", "Reversed Anticoagulation Activity [PE]", "Vitamin K [CS]", "Vitamin K [EPC]", "Warfarin Reversal Agent [EPC]"], "product_ndc": "70771-1318", "generic_name": "Phytonadione", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "5 mg/1"}], "application_number": "ANDA210189", "marketing_category": "ANDA", "marketing_start_date": "20190222", "listing_expiration_date": "20261231"}