Phytonadione

Product NDC
72134-008
11-digit product format
721340008
Labeler code
72134
Product ID
72134-008_efc664b8-931d-4577-8b06-9653637eb89a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Agnitio Inc.
Application
ANDA213336
Marketing category
ANDA
Marketing start
2022-02-11
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
72134-008-01Phytonadione100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72134-008PHYTONADIONE TABLET [AGNITIO INC.]2Current NDC, 1 package rows20241206_66ada4f8-c5a9-49f1-848f-e172416892a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN66ada4f8-c5a9-49f1-848f-e172416892a13
198102vitamin K1 5 MG Oral TabletSCD66ada4f8-c5a9-49f1-848f-e172416892a13
198102phytonadione 5 MG Oral TabletSY66ada4f8-c5a9-49f1-848f-e172416892a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72134-008-0172134000801100 TABLET in 1 BOTTLE (72134-008-01) 100 tablet2022-02-11NoNoHistorical