Phytonadione

Product NDC
0904-6882
11-digit product format
009046882
Labeler code
0904
Product ID
0904-6882_c18b843e-3f3e-4314-bf6d-b1e5bfaaf84b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA209373
Marketing category
ANDA
Marketing start
2018-05-15
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
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6882-10Phytonadione20 in 1 CARTONTABLET206
0904-6882-10Phytonadione1 in 1 BLISTER PACKTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6882-10EA - Each0904-688258161a3a-9280-4d33-b77b-9f5f2cb133a712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6882PHYTONADIONE TABLET [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250305_54f23bc8-d8f3-40e8-a93d-3121cc581d54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN54f23bc8-d8f3-40e8-a93d-3121cc581d546
198102vitamin K1 5 MG Oral TabletSCD54f23bc8-d8f3-40e8-a93d-3121cc581d546
198102phytonadione 5 MG Oral TabletSY54f23bc8-d8f3-40e8-a93d-3121cc581d546

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6882-100090468821020 BLISTER PACK in 1 CARTON (0904-6882-10) / 1 TABLET in 1 BLISTER PACK20 blister pack2018-05-150000-00-00NoNoCurrent