Nafcillin

Product NDC
83634-101
11-digit product format
836340101
Labeler code
83634
Product ID
83634-101_7a4b6e14-65c7-456d-999a-eb8dacaaeece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nafcillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy Inc.
Application
ANDA090005
Marketing category
ANDA
Marketing start
2025-02-01
Substance
NAFCILLIN SODIUM
Active strength
10 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 SODIUM10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii49G3001BCK
Rxcui239189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b7b0726e-639a-4536-8d6a-d050fc34e9d8Product name220200528
f189d2f2-ff03-d646-79ae-649b7a3d8e3fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-101-99Nafcillin100 mL in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION1001
83634-101-99Nafcillin1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-101NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AVENACY INC.]1Current NDC, 2 package rows20250201_0556378a-b794-4235-ba09-ebdc295e9092.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239189nafcillin 100 MG/ML Injectable SolutionPSN0556378a-b794-4235-ba09-ebdc295e90921
239189nafcillin 100 MG/ML Injectable SolutionSCD0556378a-b794-4235-ba09-ebdc295e90921
239189nafcillin (as nafcillin sodium) 100 MG/ML Injectable SolutionSY0556378a-b794-4235-ba09-ebdc295e90921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-101-99836340101991 BOTTLE in 1 CARTON (83634-101-99) / 100 mL in 1 BOTTLE1 bottle2025-02-01NoNoCurrent