FDA.reportPublic FDA data

MEPHYTON

Product NDC
21695-168
11-digit product format
216950168
Labeler code
21695
Product ID
21695-168_4150414d-ed40-4055-ab75-7e17627ce7c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA010104
Marketing category
NDA
Marketing start
1955-09-30
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-168-102019-09-24C16284748780-1934fe258-4797-48b1-e053-8cdaa90a720aMEPHYTON ® (PHYTONADIONE) TABLETS Vitamin K 1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-168-10MEPHYTON10 in 1 BOTTLETABLET101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-168-10EA - Each21695-168c83c59cf-cc5b-4fbb-abfd-2b32e0feaefc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
phytonadioneACTIVE INGREDIENTA034SE7857MEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1
phytonadioneACTIVE MOIETYA034SE7857MEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1
ACACIAINACTIVE INGREDIENT5C5403N26OMEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXMEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UMEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-168MEPHYTON (PHYTONADIONE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110104_4150414d-ed40-4055-ab75-7e17627ce7c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207839Mephyton 5 MG Oral TabletPSN4150414d-ed40-4055-ab75-7e17627ce7c61
198102phytonadione 5 MG Oral TabletPSN4150414d-ed40-4055-ab75-7e17627ce7c61
207839vitamin K1 5 MG Oral Tablet [Mephyton]SBD4150414d-ed40-4055-ab75-7e17627ce7c61
198102vitamin K1 5 MG Oral TabletSCD4150414d-ed40-4055-ab75-7e17627ce7c61
207839Mephyton 5 MG Oral TabletSY4150414d-ed40-4055-ab75-7e17627ce7c61
198102phytonadione 5 MG Oral TabletSY4150414d-ed40-4055-ab75-7e17627ce7c61
207839phytonadione 5 MG Oral Tablet [Mephyton]SY4150414d-ed40-4055-ab75-7e17627ce7c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-168-102169501681010 in 1 BOTTLEHistorical