FDA.reportPublic FDA data

Oxacillin

Product NDC
55150-127
11-digit product format
551500127
Labeler code
55150
Product ID
55150-127_0570fa17-5fe7-4647-9dde-d6097388a4e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxacillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA201539
Marketing category
ANDA
Marketing start
2013-01-18
Substance
OXACILLIN SODIUM
Active strength
1 g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxacillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXACILLIN SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG0V6C994Q5
Rxcui1743547, 1743549

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
127e7924-fd95-4662-8461-0d47883074e5Product name320210203
ddeeaac2-48c2-8216-8ed2-9c12f504c245Product name620210203
980e9fdc-5dbe-4457-ab38-34447ecf5aefProduct name120150323
044bb259-bf89-755b-5d75-d23b61ed145bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-127-15Oxacillin10 in 1 BOXINJECTION, POWDER, FOR SOLUTION1011
55150-127-15Oxacillin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-127-15EA - Each55150-12748254b5f-fc17-4271-8153-e7e258ec1abc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXACILLIN SODIUMACTIVE INGREDIENTG0V6C994Q5OXACILLIN (OXACILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION OXACILLIN (OXACILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC]4
OXACILLINACTIVE MOIETYUH95VD7V76OXACILLIN (OXACILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION OXACILLIN (OXACILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74OXACILLIN (OXACILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION OXACILLIN (OXACILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-127OXACILLIN (OXACILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION OXACILLIN (OXACILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC]10Current NDC, Legacy NDC, 2 package rows20230203_81e90279-9889-47bd-974b-334c181f295c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743547oxacillin 1 GM InjectionPSN81e90279-9889-47bd-974b-334c181f295c11
1743549oxacillin 2 GM InjectionPSN81e90279-9889-47bd-974b-334c181f295c11
1743547oxacillin 1000 MG InjectionSCD81e90279-9889-47bd-974b-334c181f295c11
1743549oxacillin 2000 MG InjectionSCD81e90279-9889-47bd-974b-334c181f295c11
1743547oxacillin (as oxacillin sodium) 1000 MG InjectionSY81e90279-9889-47bd-974b-334c181f295c11
1743549oxacillin (as oxacillin sodium) 2000 MG InjectionSY81e90279-9889-47bd-974b-334c181f295c11
1743547oxacillin 1 GM InjectionSY81e90279-9889-47bd-974b-334c181f295c11
1743549oxacillin 2 GM InjectionSY81e90279-9889-47bd-974b-334c181f295c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-127-155515001271510 VIAL in 1 BOX (55150-127-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2013-01-180000-00-00NoNoCurrent