FDA.reportPublic FDA data

Phytonadione

Product NDC
70710-1014
11-digit product format
707101014
Labeler code
70710
Product ID
70710-1014_e01282e9-c321-44ca-adc7-93d3e808fe4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA210189
Marketing category
ANDA
Marketing start
2019-02-22
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
70710-1014-1Phytonadione1 in 1 CARTONTABLET15
70710-1014-1Phytonadione100 in 1 BOTTLETABLET1005
70710-1014-2Phytonadione10 in 1 BLISTER PACKTABLET105
70710-1014-3Phytonadione30 in 1 BOTTLETABLET305
70710-1014-4Phytonadione10 in 1 CARTONTABLET105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1014-1EA - Each70710-1014df2f6f9c-96dd-4e0e-9520-89d91995965712019-03-12
70710-1014-3EA - Each70710-10146aa93e6f-dbd6-442c-8840-32f96735981212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1014PHYTONADIONE TABLET [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 5 package rows20240806_6c992275-b040-42d0-9eff-570dce4272fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN6c992275-b040-42d0-9eff-570dce4272fe5
198102vitamin K1 5 MG Oral TabletSCD6c992275-b040-42d0-9eff-570dce4272fe5
198102phytonadione 5 MG Oral TabletSY6c992275-b040-42d0-9eff-570dce4272fe5
198102phytonadione 5 MG Oral TabletPSN3e4f86c4-7e89-c864-e063-6394a90a59af1
198102vitamin K1 5 MG Oral TabletSCD3e4f86c4-7e89-c864-e063-6394a90a59af1
198102phytonadione 5 MG Oral TabletSY3e4f86c4-7e89-c864-e063-6394a90a59af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1014-1707101014011 BOTTLE in 1 CARTON (70710-1014-1) / 100 TABLET in 1 BOTTLE1 bottle2019-02-220000-00-00YesNoCurrent
70710-1014-27071010140210 in 1 BLISTER PACKHistorical
70710-1014-37071010140330 TABLET in 1 BOTTLE (70710-1014-3) 30 tablet2021-11-010000-00-00YesNoCurrent
70710-1014-47071010140410 BLISTER PACK in 1 CARTON (70710-1014-4) / 10 TABLET in 1 BLISTER PACK (70710-1014-2) 10 blister pack2019-02-220000-00-00YesNoCurrent