FDA.reportPublic FDA data

NAFCILLIN SODIUM

Product NDC
72485-406
11-digit product format
724850406
Labeler code
72485
Product ID
72485-406_453054b0-dabd-dee9-e063-6294a90abee2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAFCILLIN SODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA200002
Marketing category
ANDA
Marketing start
2023-11-01
Substance
NAFCILLIN SODIUM
Active strength
2 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
NAFCILLIN SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAFCILLIN SODIUM2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii49G3001BCK
Rxcui1721458, 1721460

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b7b0726e-639a-4536-8d6a-d050fc34e9d8Product name220200528
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
f189d2f2-ff03-d646-79ae-649b7a3d8e3fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-406-10NAFCILLIN SODIUM10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102
72485-406-10NAFCILLIN SODIUM1 in 1 VIALINJECTION, POWDER, FOR SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-406-10EA - Each72485-406c4fc405c-85ab-469f-bf73-369624db699112023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-406NAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, 2 package rows20231101_090fda61-b9c8-640e-e063-6294a90a7363.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721458nafcillin 1 GM InjectionPSN090fda61-b9c8-640e-e063-6294a90a73632
1721460nafcillin 2 GM InjectionPSN090fda61-b9c8-640e-e063-6294a90a73632
1721458nafcillin 1000 MG InjectionSCD090fda61-b9c8-640e-e063-6294a90a73632
1721460nafcillin 2000 MG InjectionSCD090fda61-b9c8-640e-e063-6294a90a73632
1721458nafcillin (as nafcillin sodium) 1 GM InjectionSY090fda61-b9c8-640e-e063-6294a90a73632
1721460nafcillin (as nafcillin sodium) 2 GM InjectionSY090fda61-b9c8-640e-e063-6294a90a73632
1721458nafcillin 1 GM InjectionSY090fda61-b9c8-640e-e063-6294a90a73632
1721460nafcillin 2 GM InjectionSY090fda61-b9c8-640e-e063-6294a90a73632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-406-107248504061010 VIAL in 1 CARTON (72485-406-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2023-11-01NoNoHistorical