FDA.reportPublic FDA data

Nafcillin

Product NDC
70860-119
11-digit product format
708600119
Labeler code
70860
Product ID
70860-119_2cc9cc61-54ac-9a94-e063-6394a90a2376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nafcillin sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA090005
Marketing category
ANDA
Marketing start
2018-08-15
Marketing end
2026-06-30
Substance
NAFCILLIN SODIUM
Active strength
10 g/100mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nafcillin

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-119-992024-03-04C16284748780-11030e365-3ef6-111a-e063-dadaa90a10e2Nafcillin for Injection, USP
70860-119-992024-01-30C16284748780-11030e365-3ef6-111a-e063-dadaa90a10e2Nafcillin for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-119-99Nafcillin1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
70860-119-99Nafcillin100 mL in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-119-99EA - Each70860-119638d59fd-9070-41be-8a60-a214b7db046812018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-119NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]4Current NDC, Legacy NDC, 2 package rows20250130_2bc91eeb-5d8d-4058-b16a-532ba114fcd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239189nafcillin 100 MG/ML Injectable SolutionPSN2bc91eeb-5d8d-4058-b16a-532ba114fcd54
239189nafcillin 100 MG/ML Injectable SolutionSCD2bc91eeb-5d8d-4058-b16a-532ba114fcd54
239189nafcillin (as nafcillin sodium) 100 MG/ML Injectable SolutionSY2bc91eeb-5d8d-4058-b16a-532ba114fcd54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-119-99708600119991 BOTTLE in 1 CARTON (70860-119-99) / 100 mL in 1 BOTTLE1 bottle2018-08-152026-06-30NoNoCurrent