FDA.reportPublic FDA data

Phytonadione

Product NDC
65219-635
11-digit product format
652190635
Labeler code
65219
Product ID
65219-635_02a39690-38e6-42e9-9897-391c2df9e07e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA219212
Marketing category
ANDA
Marketing start
2025-05-10
Substance
PHYTONADIONE
Active strength
10 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
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
PHYTONADIONE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA034SE7857
Rxcui1670192

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-635-00Phytonadione1 mL in 1 VIAL, SINGLE-DOSEINJECTION, EMULSION11
65219-635-00Phytonadione5 in 1 TRAYINJECTION, EMULSION51
65219-635-01Phytonadione2 in 1 CARTONINJECTION, EMULSION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-635-00ML - Milliliter65219-635c6e0e59e-1cb9-4e54-933f-15e90fce811212025-06-13
65219-635-01ML - Milliliter65219-635ed935ee5-312e-4a27-a220-9338f8dd654e12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-635PHYTONADIONE INJECTION, EMULSION [FRESENIUS KABI USA, LLC]1Current NDC, 3 package rows20250511_02a39690-38e6-42e9-9897-391c2df9e07e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670192phytonadione 10 MG in 1 ML InjectionPSN02a39690-38e6-42e9-9897-391c2df9e07e1
16701921 ML vitamin K1 10 MG/ML InjectionSCD02a39690-38e6-42e9-9897-391c2df9e07e1
1670192phytonadione 10 MG per 1 ML InjectionSY02a39690-38e6-42e9-9897-391c2df9e07e1
1670192vitamin K 1 10 MG per 1 ML InjectionSY02a39690-38e6-42e9-9897-391c2df9e07e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-635-00652190635001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
65219-635-01652190635012 TRAY in 1 CARTON (65219-635-01) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65219-635-00) / 1 mL in 1 VIAL, SINGLE-DOSE2 tray2025-05-10NoNoCurrent