phytonadione

Generic: phytonadione

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

phytonadione 1 mg/.5mL

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-826
Product ID 62332-826_6da12ac4-63b8-4927-917e-7856d68686f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216444
Listing Expiration 2026-12-31
Marketing Start 2025-09-08

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 62332826
Hyphenated Format 62332-826

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 ANDA216444 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (62332-826-05) / .5 mL in 1 SYRINGE
  • 10 SYRINGE in 1 CARTON (62332-826-10) / .5 mL in 1 SYRINGE
source: ndc

Packages (2)

62332-826-05 1 SYRINGE in 1 CARTON (62332-826-05) / .5 mL in 1 SYRINGE 62332-826-10 10 SYRINGE in 1 CARTON (62332-826-10) / .5 mL in 1 SYRINGE

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": "6da12ac4-63b8-4927-917e-7856d68686f4", "openfda": {"nui": ["N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["A034SE7857"], "rxcui": ["727625"], "spl_set_id": ["b1e53422-c85d-4bb6-af4f-24934cc319b0"], "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": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (62332-826-05)  / .5 mL in 1 SYRINGE", "package_ndc": "62332-826-05", "marketing_start_date": "20250908"}, {"sample": false, "description": "10 SYRINGE in 1 CARTON (62332-826-10)  / .5 mL in 1 SYRINGE", "package_ndc": "62332-826-10", "marketing_start_date": "20250908"}], "brand_name": "Phytonadione", "product_id": "62332-826_6da12ac4-63b8-4927-917e-7856d68686f4", "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": "62332-826", "generic_name": "Phytonadione", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phytonadione", "active_ingredients": [{"name": "PHYTONADIONE", "strength": "1 mg/.5mL"}], "application_number": "ANDA216444", "marketing_category": "ANDA", "marketing_start_date": "20250908", "listing_expiration_date": "20261231"}