FDA.reportPublic FDA data

CEFUROXIME AXETIL

Product NDC
61919-145
11-digit product format
619190145
Labeler code
61919
Product ID
61919-145_d45e7d8f-f4ab-4273-962a-d44b4c5633da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFUROXIME AXETIL
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA065308
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
CEFUROXIME AXETIL
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-145-202020-01-31C16284748780-19d75b9d0-219a-f424-e053-dadaa90a57ceCEFUROXIME AXETIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-145-20CEFUROXIME AXETIL20 in 1 BOTTLETABLET202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-145-20EA - Each61919-14520546098-118c-444c-926d-58e5fbad56aa12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFUROXIME AXETILACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET [DIRECT RX]2
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFUROXIME AXETIL TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFUROXIME AXETIL TABLET [DIRECT RX]2
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACEFUROXIME AXETIL TABLET [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCEFUROXIME AXETIL TABLET [DIRECT RX]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCEFUROXIME AXETIL TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFUROXIME AXETIL TABLET [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFUROXIME AXETIL TABLET [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFUROXIME AXETIL TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-145CEFUROXIME AXETIL TABLET [DIRECT RX]2Legacy NDC, 1 package rows20151104_ad1a2f81-2595-47eb-9c2e-967c4b8e26bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNad1a2f81-2595-47eb-9c2e-967c4b8e26bd2
309097cefuroxime 250 MG Oral TabletSCDad1a2f81-2595-47eb-9c2e-967c4b8e26bd2
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYad1a2f81-2595-47eb-9c2e-967c4b8e26bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-145-206191901452020 in 1 BOTTLEHistorical