Fluconazole in Sodium Chloride

Product NDC
69784-003
11-digit product format
697840003
Labeler code
69784
Product ID
69784-003_ccff069f-bd5c-41f7-a868-3e86328bb34b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole, Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Woodward Pharma Services LLC
Application
ANDA076766
Marketing category
ANDA
Marketing start
2020-05-15
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
2 mg/mL
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69784-003-062025-09-16C16284748780-1f386c64a-0bc7-0266-e053-dadaa90a7c1a08703ddd-795e-4b69-8d3e-d63bee55d6e9
69784-003-062023-01-30C16284748780-1f386c64a-0bc7-0266-e053-dadaa90a7c1a08703ddd-795e-4b69-8d3e-d63bee55d6e9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-003-06ML - Milliliter69784-0038cade047-0d46-4559-9cb1-0bda34503a6a12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-003FLUCONAZOLE IN SODIUM CHLORIDE (FLUCONAZOLE, SODIUM CHLORIDE) INJECTION [WOODWARD PHARMA SERVICES LLC]6Legacy NDC20211223_08703ddd-795e-4b69-8d3e-d63bee55d6e9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69784-003-06697840003066 BAG in 1 CARTON (69784-003-06) > 200 mL in 1 BAG6 bag2020-05-150000-00-00NoNoCurrent