FDA.reportPublic FDA data

NAFCILLIN

Product NDC
0338-1019
11-digit product format
003381019
Labeler code
0338
Product ID
0338-1019_ad3cc424-4e9f-49e8-b72b-6969ae6b16b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAFCILLIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA050655
Marketing category
NDA
Marketing start
1989-10-31
Substance
NAFCILLIN SODIUM
Active strength
2 g/100mL
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
NAFCILLIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAFCILLIN SODIUM2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii49G3001BCK
Rxcui1721458, 1721460

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
b7b0726e-639a-4536-8d6a-d050fc34e9d8Product name220200528
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
f189d2f2-ff03-d646-79ae-649b7a3d8e3fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-1019-48NAFCILLIN100 mL in 1 BAGINJECTION, SOLUTION10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-1019-48ML - Milliliter0338-101916077108-56fb-4801-bd89-35c1f1a0d4a812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAFCILLIN SODIUMACTIVE INGREDIENT49G3001BCKNAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
NAFCILLINACTIVE MOIETY4CNZ27M7RVNAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GNAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KNAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8
WATERINACTIVE INGREDIENT059QF0KO0RNAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1019NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]19Current NDC, Legacy NDC, 1 package rows20250502_cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721458nafcillin 1 GM InjectionPSNcd2d18c5-95a2-4fb4-bd8b-b5d39e2da41619
1721460nafcillin 2 GM InjectionPSNcd2d18c5-95a2-4fb4-bd8b-b5d39e2da41619
1721458nafcillin 1000 MG InjectionSCDcd2d18c5-95a2-4fb4-bd8b-b5d39e2da41619
1721460nafcillin 2000 MG InjectionSCDcd2d18c5-95a2-4fb4-bd8b-b5d39e2da41619
1721458nafcillin (as nafcillin sodium) 1 GM InjectionSYcd2d18c5-95a2-4fb4-bd8b-b5d39e2da41619
1721460nafcillin (as nafcillin sodium) 2 GM InjectionSYcd2d18c5-95a2-4fb4-bd8b-b5d39e2da41619
1721458nafcillin 1 GM InjectionSYcd2d18c5-95a2-4fb4-bd8b-b5d39e2da41619
1721460nafcillin 2 GM InjectionSYcd2d18c5-95a2-4fb4-bd8b-b5d39e2da41619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-1019-4800338101948100 mL in 1 BAG (0338-1019-48) 100 ml1989-10-310000-00-00NoNoCurrent