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Active ingredient

Vitamin K1

37 finished FDA listings contain Vitamin K1 as their only active ingredient; 6 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
PHYTONADIONE
Dosage forms
Injection, Emulsion, Tablet
Routes
Intramuscular, Intravenous, Oral, Parenteral, Subcutaneous
Manufacturers / labelers
31
Strengths listed
1 mg/.5ml · 10 mg/ml · 2 mg/ml · 5 mg/1
Brand names in FDA listings
Phytonadione Phytonadione, Vitamin K1, Vitamin K1 Phytonadione

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8308

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 083722INTL MEDICATION1976-03-012
ANDA 087955HOSPIRA1983-07-252
ANDA 087954HOSPIRA1983-07-252
ANDA 209373AMNEAL PHARMS CO2018-05-113
ANDA 210189ZYDUS LIFESCIENCES2019-02-205
ANDA 207719DR REDDYS2019-05-223
ANDA 214596CIPLA2022-04-222
ANDA 213329SCIEGEN PHARMS2023-07-283
ANDA 213336TP ANDA HOLDINGS2023-10-121
ANDA 217386GLAND2024-12-103
ANDA 214966CIPLA2025-01-031
ANDA 219212CAPLIN2025-04-172
ANDA 216444ALEMBIC2025-09-083
ANDA 216601AMNEAL2025-11-041
ANDA 216852BAXTER HLTHCARE CORP2026-02-261
ANDA 216298ORBICULAR2026-03-132
ANDA 217734AMNEAL2026-06-011

Official labeling on DailyMed

Showing the 12 most recent of 34 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.