Vitamin K1

Product NDC
50090-4521
11-digit product format
500904521
Labeler code
50090
Product ID
50090-4521_6230f6bc-90e0-4020-8af0-28e93f0a54f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHYTONADIONE
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
ANDA087955
Marketing category
ANDA
Marketing start
2005-07-27
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4521-02023-01-30C16284748780-1f386c649-9b22-0266-e053-dadaa90a7c1aVITAMIN K 1 INJECTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4521-0Vitamin K11 mL in 1 AMPULEINJECTION, EMULSION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4521VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [A-S MEDICATION SOLUTIONS]6Legacy NDC, 1 package rows20210615_4a203fc7-cd33-4e79-b835-d3b14d2a7f9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670192phytonadione 10 MG in 1 ML InjectionPSN4a203fc7-cd33-4e79-b835-d3b14d2a7f9d6
16701921 ML vitamin K1 10 MG/ML InjectionSCD4a203fc7-cd33-4e79-b835-d3b14d2a7f9d6
1670192phytonadione 10 MG per 1 ML InjectionSY4a203fc7-cd33-4e79-b835-d3b14d2a7f9d6
1670192vitamin K 1 10 MG per 1 ML InjectionSY4a203fc7-cd33-4e79-b835-d3b14d2a7f9d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4521-0500904521001 mL in 1 AMPULE (50090-4521-0) 1 ml2019-09-120000-00-00NoNoCurrent