Phytonadione

Product NDC: 76329-1240
11-digit product format: 763291240
Labeler code: 76329
Product ID: 76329-1240_50dd7ff3-6b34-4dbe-ab65-1c3601aba42a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phytonadione
Dosage form: INJECTION, EMULSION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: International Medication Systems, Limited
Application: ANDA083722
Marketing category: ANDA
Marketing start: 2003-04-18
Substance: PHYTONADIONE
Active strength: 1 mg/.5mL
Pharmacologic classes: Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
PHYTONADIONE	1 mg/.5mL

Field, Values table
Field	Values
Unii	A034SE7857
Rxcui	727625

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
16a2c1cd-ae95-d910-f03d-7e06b11dd243	Product name	5	20260202
653485de-0601-41e4-82db-7a60bb223e27	Product name	1	20251024
23fb3cda-2b50-f3d3-ebde-f542350bd77b	Product name	4	20240828
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76329-1240-1	Phytonadione	0.5 mL in 1 SYRINGE	INJECTION, EMULSION	0.5		8
76329-1240-1	Phytonadione	1 in 1 CARTON	INJECTION, EMULSION	1		8

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76329-1240-1	ML - Milliliter	76329-1240	54a61ac7-c002-460a-a7bc-14d8d3b3a595	1	2015-05-05
76329-1240-5	ML - Milliliter	76329-1240	b7f0b2af-116c-408f-94df-2e8497fd9eb6	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phytonadione	ACTIVE INGREDIENT	A034SE7857	PHYTONADIONE INJECTION, EMULSION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]	3
Phytonadione	ACTIVE MOIETY	A034SE7857	PHYTONADIONE INJECTION, EMULSION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]	3
PHYTONADIONE	ACTIVE INGREDIENT	A034SE7857	PHYTONADIONE INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]	1
PHYTONADIONE	ACTIVE MOIETY	A034SE7857	PHYTONADIONE INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76329-1240	PHYTONADIONE INJECTION, EMULSION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]	8	Current NDC, Legacy NDC, 2 package rows	20240327_e0b0c8f1-75be-4f25-898a-7b97b608c615.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
A034SE7857	PHYTONADIONE	PHYTONADIONE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
727625	phytonadione 1 MG in 0.5 ML Prefilled Syringe	PSN	e0b0c8f1-75be-4f25-898a-7b97b608c615	8
727625	0.5 ML vitamin K1 2 MG/ML Prefilled Syringe	SCD	e0b0c8f1-75be-4f25-898a-7b97b608c615	8
727625	0.5 ML phytonadione 2 MG/ML Prefilled Syringe	SY	e0b0c8f1-75be-4f25-898a-7b97b608c615	8
727625	phytonadione 1 MG per 0.5 ML Prefilled Syringe	SY	e0b0c8f1-75be-4f25-898a-7b97b608c615	8
727625	phytonadione 1 MG in 0.5 ML Prefilled Syringe	PSN	0d971993-466c-46dd-bdd6-2e300173621e	5
727625	0.5 ML vitamin K1 2 MG/ML Prefilled Syringe	SCD	0d971993-466c-46dd-bdd6-2e300173621e	5
727625	0.5 ML phytonadione 2 MG/ML Prefilled Syringe	SY	0d971993-466c-46dd-bdd6-2e300173621e	5
727625	phytonadione 1 MG per 0.5 ML Prefilled Syringe	SY	0d971993-466c-46dd-bdd6-2e300173621e	5
727625	phytonadione 1 MG in 0.5 ML Prefilled Syringe	PSN	4a4e56d0-b466-42d5-91ef-f4a33409bbc5	2
727625	0.5 ML vitamin K1 2 MG/ML Prefilled Syringe	SCD	4a4e56d0-b466-42d5-91ef-f4a33409bbc5	2
727625	0.5 ML phytonadione 2 MG/ML Prefilled Syringe	SY	4a4e56d0-b466-42d5-91ef-f4a33409bbc5	2
727625	phytonadione 1 MG per 0.5 ML Prefilled Syringe	SY	4a4e56d0-b466-42d5-91ef-f4a33409bbc5	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76329-1240-1	76329124001	1 SYRINGE in 1 CARTON (76329-1240-1) / .5 mL in 1 SYRINGE	1 syringe	2003-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHYTONADIONE	Henry Schein, Inc.	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	5
Phytonadione	International Medication Systems, Limited	2024-03-12	HUMAN PRESCRIPTION DRUG LABEL	8
PHYTONADIONE INJECTABLE EMULSION, USP Aqueous Colloidal Solution of Vitamin K1 Rx Only	General Injectables & Vaccines, Inc	2017-01-19	HUMAN PRESCRIPTION DRUG LABEL	2