FDA.reportPublic FDA data

Phytonadione

Product NDC
69097-003
11-digit product format
690970003
Labeler code
69097
Product ID
69097-003_d0d625e2-d304-4382-bd6a-e714de668f13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
ANDA214966
Marketing category
ANDA
Marketing start
2025-01-15
Substance
PHYTONADIONE
Active strength
1 mg/.5mL
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
PHYTONADIONE1 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA034SE7857
Rxcui727625

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-003-67Phytonadione0.5 mL in 1 SYRINGEINJECTION, EMULSION0.52
69097-003-96Phytonadione10 in 1 CARTONINJECTION, EMULSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-003-67ML - Milliliter69097-0033608d6ea-bcea-4ba3-9211-6ca9cc15178012025-05-14
69097-003-96ML - Milliliter69097-0033a75814a-111c-4524-a0b1-363015554c0712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-003PHYTONADIONE INJECTION, EMULSION [CIPLA USA INC.]2Current NDC, 2 package rows20250115_4bc2de7b-6564-4d77-8a65-6be57b706093.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727625phytonadione 1 MG in 0.5 ML Prefilled SyringePSN4bc2de7b-6564-4d77-8a65-6be57b7060932
7276250.5 ML vitamin K1 2 MG/ML Prefilled SyringeSCD4bc2de7b-6564-4d77-8a65-6be57b7060932
7276250.5 ML phytonadione 2 MG/ML Prefilled SyringeSY4bc2de7b-6564-4d77-8a65-6be57b7060932
727625phytonadione 1 MG per 0.5 ML Prefilled SyringeSY4bc2de7b-6564-4d77-8a65-6be57b7060932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-003-67690970003670.5 mL in 1 SYRINGE0.5 mlHistorical
69097-003-966909700039610 SYRINGE in 1 CARTON (69097-003-96) / .5 mL in 1 SYRINGE (69097-003-67) 10 syringe2025-01-15NoNoHistorical