Fluconazole

Product NDC
55700-916
11-digit product format
557000916
Labeler code
55700
Product ID
55700-916_c5886538-a50f-4bed-9d8c-ee3dd287cfa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA076658
Marketing category
ANDA
Marketing start
2021-07-13
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
150 mg/1
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-916FLUCONAZOLE TABLET [QUALITY CARE PRODUCTS, LLC]4Legacy NDC20241220_b27a22b7-9ac1-45f5-9bb1-536f2792ff98.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-916-01557000916011 TABLET in 1 DOSE PACK (55700-916-01) 1 tablet2021-07-130000-00-00NoNoCurrent