Phytonadione

Product NDC
42291-566
11-digit product format
422910566
Labeler code
42291
Product ID
42291-566_487102e3-f317-836b-e063-6394a90a4438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA209373
Marketing category
ANDA
Marketing start
2023-09-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phytonadione
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-566-30Phytonadione1 in 1 BOXTABLET12
42291-566-30Phytonadione30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-566-30EA - Each42291-566bbf8c6b5-7cb2-4a12-830e-f2d4687b29e912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-566PHYTONADIONE TABLET [AVKARE]1Current NDC, 2 package rows20230908_04c776dd-b60d-23f6-e063-6394a90a247c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN04c776dd-b60d-23f6-e063-6394a90a247c2
198102vitamin K1 5 MG Oral TabletSCD04c776dd-b60d-23f6-e063-6394a90a247c2
198102phytonadione 5 MG Oral TabletSY04c776dd-b60d-23f6-e063-6394a90a247c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-566-30422910566301 BOTTLE in 1 BOX (42291-566-30) / 30 TABLET in 1 BOTTLE1 bottle2023-09-07NoNoCurrent