FDA.reportPublic FDA data

PHYTONADIONE

Product NDC
43598-405
11-digit product format
435980405
Labeler code
43598
Product ID
43598-405_c4a2bf44-0ad2-c0d2-164f-562ba6df930c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHYTONADIONE
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA207719
Marketing category
ANDA
Marketing start
2019-05-31
Substance
PHYTONADIONE
Active strength
10 mg/mL
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
Brand name suffix
PHYTONADIONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHYTONADIONE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA034SE7857
Rxcui1670192

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-405-11PHYTONADIONE PHYTONADIONE1 mL in 1 AMPULEINJECTION, EMULSION15
43598-405-16PHYTONADIONE PHYTONADIONE25 in 1 CARTONINJECTION, EMULSION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-405-11ML - Milliliter43598-4052a8956e1-c162-4e7a-93bd-d916f512841412019-07-02
43598-405-16ML - Milliliter43598-4053df6eb54-eb78-4859-b82b-2da73f3128c212019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-405PHYTONADIONE PHYTONADIONE (PHYTONADIONE) INJECTION, EMULSION [DR.REDDY'S LABORATORIES INC]5Current NDC, Legacy NDC, 2 package rows20220827_02445c07-7b4b-cd70-54e8-ebefc814f547.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670192phytonadione 10 MG in 1 ML InjectionPSN02445c07-7b4b-cd70-54e8-ebefc814f5475
1670192phytonadione 10 MG in 1 ML InjectionPSN1cf90be3-a744-4db5-999d-a84c673723045
16701921 ML vitamin K1 10 MG/ML InjectionSCD02445c07-7b4b-cd70-54e8-ebefc814f5475
16701921 ML vitamin K1 10 MG/ML InjectionSCD1cf90be3-a744-4db5-999d-a84c673723045
1670192phytonadione 10 MG per 1 ML InjectionSY02445c07-7b4b-cd70-54e8-ebefc814f5475
1670192phytonadione 10 MG per 1 ML InjectionSY1cf90be3-a744-4db5-999d-a84c673723045
1670192vitamin K 1 10 MG per 1 ML InjectionSY02445c07-7b4b-cd70-54e8-ebefc814f5475
1670192vitamin K 1 10 MG per 1 ML InjectionSY1cf90be3-a744-4db5-999d-a84c673723045

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-405-11435980405111 mL in 1 AMPULE1 mlHistorical
43598-405-164359804051625 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11) 25 ampule2019-05-310000-00-00NoNoCurrent