Phytonadione

Product NDC
16714-973
11-digit product format
167140973
Labeler code
16714
Product ID
16714-973_36fd9f1d-be83-4b1f-bf3d-149b3c942af8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA210189
Marketing category
ANDA
Marketing start
2022-03-22
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
16714-973-01Phytonadione100 in 1 BOTTLETABLET1005
16714-973-01Phytonadione1 in 1 CARTONTABLET15
16714-973-02Phytonadione1 in 1 CARTONTABLET15
16714-973-02Phytonadione30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-973-01EA - Each16714-973941bbb14-b501-4bf3-bd4a-59bb10d4e5f612019-12-10
16714-973-02EA - Each16714-973d7e343a1-6943-4270-be0c-2ef7c91849c112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-973PHYTONADIONE TABLET [NORTHSTAR RX LLC.]5Current NDC, Legacy NDC, 4 package rows20240806_5429b58b-ec2b-4a18-95d9-a9d804321192.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN5429b58b-ec2b-4a18-95d9-a9d8043211925
198102vitamin K1 5 MG Oral TabletSCD5429b58b-ec2b-4a18-95d9-a9d8043211925
198102phytonadione 5 MG Oral TabletSY5429b58b-ec2b-4a18-95d9-a9d8043211925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-973-01167140973011 BOTTLE in 1 CARTON (16714-973-01) > 100 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
16714-973-02167140973021 BOTTLE in 1 CARTON (16714-973-02) / 30 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00YesNoCurrent