FDA.reportPublic FDA data

Phytonadione

Product NDC
69238-1051
11-digit product format
692381051
Labeler code
69238
Product ID
69238-1051_94d89db9-981d-4fc5-b6fe-5d4b73230e35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69238-1051-12024-04-26C16284748780-11030e365-4d7d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955
69238-1051-32024-04-26C16284748780-11030e365-4d7d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955
69238-1051-12024-01-30C16284748780-11030e365-4d7d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955
69238-1051-32024-01-30C16284748780-11030e365-4d7d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral use Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1051-1Phytonadione100 in 1 BOTTLETABLET1006
69238-1051-1Phytonadione1 in 1 CARTONTABLET16
69238-1051-3Phytonadione1 in 1 CARTONTABLET16
69238-1051-3Phytonadione30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1051-1EA - Each69238-10514aa62a11-2098-4d66-905e-ac3703071e4a12018-06-11
69238-1051-3EA - Each69238-10515aa4f599-ab95-4d4e-96a9-4fa48fb4a4dc12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1051PHYTONADIONE TABLET [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, Legacy NDC, 4 package rows20241219_54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d6
198102phytonadione 5 MG Oral TabletPSN54f23bc8-d8f3-40e8-a93d-3121cc581d546
198102vitamin K1 5 MG Oral TabletSCD54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d6
198102vitamin K1 5 MG Oral TabletSCD54f23bc8-d8f3-40e8-a93d-3121cc581d546
198102phytonadione 5 MG Oral TabletSY54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d6
198102phytonadione 5 MG Oral TabletSY54f23bc8-d8f3-40e8-a93d-3121cc581d546
198102phytonadione 5 MG Oral TabletPSN88d13044-6ce8-4374-86ff-e8d9eea278295
198102vitamin K1 5 MG Oral TabletSCD88d13044-6ce8-4374-86ff-e8d9eea278295
198102phytonadione 5 MG Oral TabletSY88d13044-6ce8-4374-86ff-e8d9eea278295
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 startMarketing endSampleExclude flagStatus
69238-1051-1692381051011 BOTTLE in 1 CARTON (69238-1051-1) / 100 TABLET in 1 BOTTLE1 bottle2018-05-150000-00-00NoNoCurrent
69238-1051-3692381051031 BOTTLE in 1 CARTON (69238-1051-3) / 30 TABLET in 1 BOTTLE1 bottle2018-05-150000-00-00NoNoCurrent