FDA.reportPublic FDA data

Phytonadione

Product NDC
46708-826
11-digit product format
467080826
Labeler code
46708
Product ID
46708-826_6ccb76ab-1549-4a47-a119-8059588ad83d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA216444
Marketing category
ANDA
Marketing start
2025-09-08
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#

Finished product
Yes
Brand name base
Phytonadione
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHYTONADIONE1 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA034SE7857
Rxcui727625

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-826-05Phytonadione1 in 1 CARTONINJECTION, EMULSION11
46708-826-05Phytonadione0.5 mL in 1 SYRINGEINJECTION, EMULSION0.51
46708-826-10Phytonadione0.5 mL in 1 SYRINGEINJECTION, EMULSION0.51
46708-826-10Phytonadione10 in 1 CARTONINJECTION, EMULSION101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727625phytonadione 1 MG in 0.5 ML Prefilled SyringePSN6ccb76ab-1549-4a47-a119-8059588ad83d1
7276250.5 ML vitamin K1 2 MG/ML Prefilled SyringeSCD6ccb76ab-1549-4a47-a119-8059588ad83d1
7276250.5 ML phytonadione 2 MG/ML Prefilled SyringeSY6ccb76ab-1549-4a47-a119-8059588ad83d1
727625phytonadione 1 MG per 0.5 ML Prefilled SyringeSY6ccb76ab-1549-4a47-a119-8059588ad83d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-826-05467080826051 SYRINGE in 1 CARTON (46708-826-05) / .5 mL in 1 SYRINGE1 syringe2025-09-08NoNoHistorical
46708-826-104670808261010 SYRINGE in 1 CARTON (46708-826-10) / .5 mL in 1 SYRINGE10 syringe2025-09-08NoNoHistorical