FDA.reportPublic FDA data

Phytonadione

Product NDC
69097-999
11-digit product format
690970999
Labeler code
69097
Product ID
69097-999_82b768e9-502a-4b78-8200-c6bc4d0d76b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA., Inc.
Application
ANDA213329
Marketing category
ANDA
Marketing start
2023-12-01
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
69097-999-02Phytonadione30 in 1 BOTTLETABLET301
69097-999-07Phytonadione100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-999-02EA - Each69097-9999bcbb59d-714c-4310-aaad-aa640bb13fee12024-02-14
69097-999-07EA - Each69097-999b008a623-1e1a-4441-935e-6abf2c9b640e12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-999PHYTONADIONE TABLET [CIPLA USA., INC.]1Current NDC, 2 package rows20240110_7dd1f275-94d3-45d2-a4d0-696ce60a2a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198102phytonadione 5 MG Oral TabletPSN7dd1f275-94d3-45d2-a4d0-696ce60a2a9b1
198102vitamin K1 5 MG Oral TabletSCD7dd1f275-94d3-45d2-a4d0-696ce60a2a9b1
198102phytonadione 5 MG Oral TabletSY7dd1f275-94d3-45d2-a4d0-696ce60a2a9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-999-026909709990230 TABLET in 1 BOTTLE (69097-999-02) 30 tablet2023-12-01NoNoHistorical
69097-999-0769097099907100 TABLET in 1 BOTTLE (69097-999-07) 100 tablet2023-12-01NoNoHistorical