FDA.reportPublic FDA data

Oxacillin

Product NDC
64679-698
11-digit product format
646790698
Labeler code
64679
Product ID
64679-698_41e41b69-1cdb-60eb-e063-6394a90a1abe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxacillin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Wockhardt USA LLC.
Application
ANDA207147
Marketing category
ANDA
Marketing start
2017-07-31
Substance
OXACILLIN SODIUM
Active strength
1 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 SODIUM1 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
64679-698-01Oxacillin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION105
64679-698-02Oxacillin20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION205
64679-698-03Oxacillin1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-698-01EA - Each64679-69883f03f71-ad53-44a3-97c3-4cedd4e31ede12018-04-19
64679-698-02EA - Each64679-698e2b9576c-e692-4dab-8d56-5911fdee989512018-04-19
64679-698-03EA - Each64679-6981781eb62-bc60-4a7c-b4f2-0c19eb5003bb12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-698OXACILLIN (OXACILLIN) INJECTION, POWDER, FOR SOLUTION [WOCKHARDT USA LLC.]4Current NDC, Legacy NDC, 3 package rows20231123_195c2054-0746-421d-8b20-8c751bdd772b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743547oxacillin 1 GM InjectionPSN195c2054-0746-421d-8b20-8c751bdd772b5
1743549oxacillin 2 GM InjectionPSN195c2054-0746-421d-8b20-8c751bdd772b5
1743547oxacillin 1000 MG InjectionSCD195c2054-0746-421d-8b20-8c751bdd772b5
1743549oxacillin 2000 MG InjectionSCD195c2054-0746-421d-8b20-8c751bdd772b5
1743547oxacillin (as oxacillin sodium) 1000 MG InjectionSY195c2054-0746-421d-8b20-8c751bdd772b5
1743549oxacillin (as oxacillin sodium) 2000 MG InjectionSY195c2054-0746-421d-8b20-8c751bdd772b5
1743547oxacillin 1 GM InjectionSY195c2054-0746-421d-8b20-8c751bdd772b5
1743549oxacillin 2 GM InjectionSY195c2054-0746-421d-8b20-8c751bdd772b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-698-016467906980110 VIAL in 1 CARTON (64679-698-01) / 20 mL in 1 VIAL (64679-698-02) 10 vial2017-07-310000-00-00NoNoCurrent
64679-698-026467906980220 mL in 1 VIAL20 mlHistorical
64679-698-03646790698031 VIAL in 1 CARTON (64679-698-03) > 20 mL in 1 VIAL (64679-698-02) 1 vial2017-07-310000-00-00NoNoCurrent