Phytonadione

Product NDC
70771-1318
11-digit product format
707711318
Labeler code
70771
Product ID
70771-1318_40070531-4723-48f2-89b4-9efde4d1c71f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
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
70771-1318-1Phytonadione1 in 1 CARTONTABLET16
70771-1318-1Phytonadione100 in 1 BOTTLETABLET1006
70771-1318-2Phytonadione10 in 1 BLISTER PACKTABLET106
70771-1318-3Phytonadione30 in 1 BOTTLETABLET306
70771-1318-4Phytonadione10 in 1 CARTONTABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1318PHYTONADIONE TABLET [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 5 package rows20221107_fa26f747-c64e-4090-a0cf-de3d3d9b004c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSNfa26f747-c64e-4090-a0cf-de3d3d9b004c6
198102vitamin K1 5 MG Oral TabletSCDfa26f747-c64e-4090-a0cf-de3d3d9b004c6
198102phytonadione 5 MG Oral TabletSYfa26f747-c64e-4090-a0cf-de3d3d9b004c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1318-1707711318011 BOTTLE in 1 CARTON (70771-1318-1) / 100 TABLET in 1 BOTTLE1 bottle2019-02-220000-00-00NoNoCurrent
70771-1318-27077113180210 in 1 BLISTER PACKHistorical
70771-1318-37077113180330 TABLET in 1 BOTTLE (70771-1318-3) 30 tablet2021-11-010000-00-00NoNoCurrent
70771-1318-47077113180410 BLISTER PACK in 1 CARTON (70771-1318-4) / 10 TABLET in 1 BLISTER PACK (70771-1318-2) 10 blister pack2019-02-220000-00-00NoNoCurrent