FDA.reportPublic FDA data

Phytonadione

Product NDC
69097-709
11-digit product format
690970709
Labeler code
69097
Product ID
69097-709_b3dd9cac-1295-48b6-b9b1-48d36cb732b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
ANDA214596
Marketing category
ANDA
Marketing start
2022-04-27
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
Rxcui312424, 1670192

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-709-96Phytonadione10 in 1 CARTONINJECTION, EMULSION105
69097-709-96Phytonadione0.5 mL in 1 VIALINJECTION, EMULSION0.55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-709-96ML - Milliliter69097-70902252760-4176-405b-801f-b0925ea0400212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-709PHYTONADIONE INJECTION, EMULSION [CIPLA USA INC.]5Current NDC, Legacy NDC, 2 package rows20240713_1add4de5-0f9c-453e-9dd5-abb8077b566a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312424phytonadione 1 MG in 0.5 ML InjectionPSN1add4de5-0f9c-453e-9dd5-abb8077b566a5
1670192phytonadione 10 MG in 1 ML InjectionPSN1add4de5-0f9c-453e-9dd5-abb8077b566a5
3124240.5 ML vitamin K1 2 MG/ML InjectionSCD1add4de5-0f9c-453e-9dd5-abb8077b566a5
16701921 ML vitamin K1 10 MG/ML InjectionSCD1add4de5-0f9c-453e-9dd5-abb8077b566a5
312424phytonadione 1 MG per 0.5 ML InjectionSY1add4de5-0f9c-453e-9dd5-abb8077b566a5
1670192phytonadione 10 MG per 1 ML InjectionSY1add4de5-0f9c-453e-9dd5-abb8077b566a5
1670192vitamin K 1 10 MG per 1 ML InjectionSY1add4de5-0f9c-453e-9dd5-abb8077b566a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-709-966909707099610 VIAL in 1 CARTON (69097-709-96) / .5 mL in 1 VIAL10 vial2022-04-270000-00-00NoNoCurrent