Vitamin K1

Product NDC: 0409-9157
11-digit product format: 004099157
Labeler code: 0409
Product ID: 0409-9157_42b6397b-1ec3-4182-95cf-e2dfe5c19a28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHYTONADIONE
Dosage form: INJECTION, EMULSION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hospira, Inc.
Application: ANDA087954
Marketing category: ANDA
Marketing start: 2005-06-22
Substance: PHYTONADIONE
Active strength: 2 mg/mL
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: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
PHYTONADIONE	2 mg/mL

Field, Values table
Field	Values
Unii	A034SE7857
Rxcui	312424, 1670192

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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-9157-01	Vitamin K1	5 in 1 CONTAINER	INJECTION, EMULSION	5	22
0409-9157-31	Vitamin K1	0.5 mL in 1 AMPULE	INJECTION, EMULSION	0.5	22
0409-9157-50	Vitamin K1	5 in 1 TRAY	INJECTION, EMULSION	5	22

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-9157-01	ML - Milliliter	0409-9157	4b6a3151-7faf-490f-a44d-2eb7b33591eb	1	2012-07-24
0409-9157-25	ML - Milliliter	0409-9157	d2e6c6cd-2a7f-47d3-b960-213e37d820a3	1	2014-11-05
0409-9157-31	ML - Milliliter	0409-9157	15ddf269-d1db-4562-9bf0-8a13044f9b84	1	2019-08-06
0409-9157-50	ML - Milliliter	0409-9157	780cd970-f468-4055-ab57-403f9bc52588	1	2019-08-06

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHYTONADIONE	ACTIVE INGREDIENT	A034SE7857	VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]	12
PHYTONADIONE	ACTIVE MOIETY	A034SE7857	VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]	12
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]	12
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]	12
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]	12
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]	12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-9157	VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]	20	Current NDC, Legacy NDC, 3 package rows	20241207_e8808230-2c44-44c6-8cab-8f29b6b34051.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
312424	phytonadione 1 MG in 0.5 ML Injection	PSN	e8808230-2c44-44c6-8cab-8f29b6b34051	22
1670192	phytonadione 10 MG in 1 ML Injection	PSN	e8808230-2c44-44c6-8cab-8f29b6b34051	22
312424	0.5 ML vitamin K1 2 MG/ML Injection	SCD	e8808230-2c44-44c6-8cab-8f29b6b34051	22
1670192	1 ML vitamin K1 10 MG/ML Injection	SCD	e8808230-2c44-44c6-8cab-8f29b6b34051	22
312424	phytonadione 1 MG per 0.5 ML Injection	SY	e8808230-2c44-44c6-8cab-8f29b6b34051	22
1670192	phytonadione 10 MG per 1 ML Injection	SY	e8808230-2c44-44c6-8cab-8f29b6b34051	22
1670192	vitamin K 1 10 MG per 1 ML Injection	SY	e8808230-2c44-44c6-8cab-8f29b6b34051	22
312424	phytonadione 1 MG in 0.5 ML Injection	PSN	f922f301-f5ab-4db8-b6a6-364f95fff09c	8
312424	0.5 ML vitamin K1 2 MG/ML Injection	SCD	f922f301-f5ab-4db8-b6a6-364f95fff09c	8
312424	phytonadione 1 MG per 0.5 ML Injection	SY	f922f301-f5ab-4db8-b6a6-364f95fff09c	8
312424	phytonadione 1 MG in 0.5 ML Injection	PSN	cfc0df9f-ee59-9e30-e053-2995a90ad449	3
312424	0.5 ML vitamin K1 2 MG/ML Injection	SCD	cfc0df9f-ee59-9e30-e053-2995a90ad449	3
312424	phytonadione 1 MG per 0.5 ML Injection	SY	cfc0df9f-ee59-9e30-e053-2995a90ad449	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-9157-01	00409915701	5 TRAY in 1 CONTAINER (0409-9157-01) / 5 AMPULE in 1 TRAY (0409-9157-50) / .5 mL in 1 AMPULE (0409-9157-31)	5 tray	2005-06-22	0000-00-00	No	No	Current
0409-9157-31	00409915731	0.5 mL in 1 AMPULE	0.5 ml					Historical
0409-9157-50	00409915750	5 in 1 TRAY						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vitamin K1	Hospira, Inc.	2026-05-25	HUMAN PRESCRIPTION DRUG LABEL	22
VITAMIN K1 PHYTONADIONE	HF Acquisition Co LLC, DBA HealthFirst	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	3
VITAMIN K 1 INJECTION	A-S Medication Solutions	2021-06-14	HUMAN PRESCRIPTION DRUG LABEL	8