PHYTONADIONE

Product NDC
43066-132
11-digit product format
430660132
Labeler code
43066
Product ID
43066-132_98fa1675-8af1-42c5-bbab-8b3632d52a0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHYTONADIONE
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA216852
Marketing category
ANDA
Marketing start
2026-02-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHYTONADIONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHYTONADIONE1 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA034SE7857
Rxcui312424

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43066-132-10PHYTONADIONE10 in 1 CARTONINJECTION, EMULSION101
43066-132-10PHYTONADIONE0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, EMULSION0.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43066-132-10ML - Milliliter43066-1324e70e035-3890-4709-af74-43b77407184912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312424phytonadione 1 MG in 0.5 ML InjectionPSN98fa1675-8af1-42c5-bbab-8b3632d52a0f1
3124240.5 ML vitamin K1 2 MG/ML InjectionSCD98fa1675-8af1-42c5-bbab-8b3632d52a0f1
312424phytonadione 1 MG per 0.5 ML InjectionSY98fa1675-8af1-42c5-bbab-8b3632d52a0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43066-132-104306601321010 VIAL, SINGLE-DOSE in 1 CARTON (43066-132-10) / .5 mL in 1 VIAL, SINGLE-DOSE2026-02-26NoNoCurrent