FDA.reportPublic FDA data

Phytonadione

Product NDC
60687-381
11-digit product format
606870381
Labeler code
60687
Product ID
60687-381_22df1183-63b6-9572-e063-6394a90ae974
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209373
Marketing category
ANDA
Marketing start
2018-06-21
Substance
PHYTONADIONE
Active strength
5 mg/1
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
PHYTONADIONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA034SE7857
Rxcui198102

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
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-381-11Phytonadione1 in 1 BLISTER PACKTABLET15
60687-381-94Phytonadione20 in 1 BOX, UNIT-DOSETABLET205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-381-11EA - Each60687-3816418904a-09b2-41ce-b44a-e950afafa8fd12018-07-03
60687-381-94EA - Each60687-38143e0faac-d2b9-4ce5-a3bd-6e27e481cb9112018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-381PHYTONADIONE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20240926_88d13044-6ce8-4374-86ff-e8d9eea27829.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN88d13044-6ce8-4374-86ff-e8d9eea278295
198102vitamin K1 5 MG Oral TabletSCD88d13044-6ce8-4374-86ff-e8d9eea278295
198102phytonadione 5 MG Oral TabletSY88d13044-6ce8-4374-86ff-e8d9eea278295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-381-11606870381111 in 1 BLISTER PACKHistorical
60687-381-946068703819420 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-381-94) / 1 TABLET in 1 BLISTER PACK (60687-381-11) 20 blister pack2018-06-210000-00-00NoNoCurrent