Phytonadione

Product NDC
67046-1581
11-digit product format
670461581
Labeler code
67046
Product ID
67046-1581_3e4f86c4-7e70-c864-e063-6394a90a59af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA210189
Marketing category
ANDA
Marketing start
2025-09-08
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
67046-1581-3Phytonadione30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN3e4f86c4-7e89-c864-e063-6394a90a59af1
198102vitamin K1 5 MG Oral TabletSCD3e4f86c4-7e89-c864-e063-6394a90a59af1
198102phytonadione 5 MG Oral TabletSY3e4f86c4-7e89-c864-e063-6394a90a59af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1581-36704615810330 TABLET in 1 BLISTER PACK (67046-1581-3) 30 tablet2025-09-08NoNoHistorical