FDA.reportPublic FDA data

Phytonadione

Product NDC
65145-151
11-digit product format
651450151
Labeler code
65145
Product ID
65145-151_114b1330-6f03-476c-8678-8cd0da189bce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Caplin Steriles Limited
Application
ANDA219212
Marketing category
ANDA
Marketing start
2025-04-26
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
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
65145-151-01Phytonadione1 mL in 1 VIAL, SINGLE-DOSEINJECTION, EMULSION11
65145-151-05Phytonadione5 in 1 TRAYINJECTION, EMULSION51
65145-151-10Phytonadione2 in 1 CARTONINJECTION, EMULSION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-151-01ML - Milliliter65145-15173a6f1bd-f8c2-417a-a9f2-d6c66b056b0d12025-06-13
65145-151-10ML - Milliliter65145-15191076d03-fee1-45e0-a866-6865ac13f5df12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-151PHYTONADIONE INJECTION, EMULSION [CAPLIN STERILES LIMITED]1Current NDC, 3 package rows20250428_114b1330-6f03-476c-8678-8cd0da189bce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670192phytonadione 10 MG in 1 ML InjectionPSN114b1330-6f03-476c-8678-8cd0da189bce1
16701921 ML vitamin K1 10 MG/ML InjectionSCD114b1330-6f03-476c-8678-8cd0da189bce1
1670192phytonadione 10 MG per 1 ML InjectionSY114b1330-6f03-476c-8678-8cd0da189bce1
1670192vitamin K 1 10 MG per 1 ML InjectionSY114b1330-6f03-476c-8678-8cd0da189bce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-151-01651450151011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
65145-151-05651450151055 in 1 TRAYHistorical
65145-151-10651450151102 TRAY in 1 CARTON (65145-151-10) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65145-151-05) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-151-01) 2 tray2025-04-26NoNoCurrent