FDA.reportPublic FDA data

Oxacillin

Product NDC
63323-812
11-digit product format
633230812
Labeler code
63323
Product ID
63323-812_c7907a70-1efa-46eb-b046-fcf043fdb413
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxacillin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA206198
Marketing category
ANDA
Marketing start
2020-11-01
Substance
OXACILLIN SODIUM
Active strength
2 g/20mL
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 SODIUM2 g/20mL

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
63323-812-01Oxacillin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION203
63323-812-20Oxacillin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-812-01EA - Each63323-8125afc1037-185e-4cc3-b68e-efb1e05d3b6e12021-01-08
63323-812-20EA - Each63323-812397fb0d1-cb81-4c3d-a938-5b860dca826612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-812OXACILLIN INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20201101_af2dccac-98c8-488f-a133-6374b3ca8dba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743547oxacillin 1 GM InjectionPSNaf2dccac-98c8-488f-a133-6374b3ca8dba3
1743549oxacillin 2 GM InjectionPSNaf2dccac-98c8-488f-a133-6374b3ca8dba3
1743547oxacillin 1000 MG InjectionSCDaf2dccac-98c8-488f-a133-6374b3ca8dba3
1743549oxacillin 2000 MG InjectionSCDaf2dccac-98c8-488f-a133-6374b3ca8dba3
1743547oxacillin (as oxacillin sodium) 1000 MG InjectionSYaf2dccac-98c8-488f-a133-6374b3ca8dba3
1743549oxacillin (as oxacillin sodium) 2000 MG InjectionSYaf2dccac-98c8-488f-a133-6374b3ca8dba3
1743547oxacillin 1 GM InjectionSYaf2dccac-98c8-488f-a133-6374b3ca8dba3
1743549oxacillin 2 GM InjectionSYaf2dccac-98c8-488f-a133-6374b3ca8dba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-812-016332308120120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-812-206332308122010 VIAL, SINGLE-DOSE in 1 CARTON (63323-812-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-812-01) 2020-11-010000-00-00NoNoCurrent