Fluconazole

Product NDC
55700-945
11-digit product format
557000945
Labeler code
55700
Product ID
55700-945_c20ea406-5af5-4eca-9d13-0304a2e487bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA077253
Marketing category
ANDA
Marketing start
2021-09-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-945-012023-12-15C16284748780-1f386c649-dfb2-0266-e053-dadaa90a7c1a65d2dc7b-f8c3-4e50-970b-a2ef209d25eb
55700-945-012023-01-30C16284748780-1f386c649-dfb2-0266-e053-dadaa90a7c1a65d2dc7b-f8c3-4e50-970b-a2ef209d25eb

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-945-01557000945011 BLISTER PACK in 1 CARTON (55700-945-01) > 1 TABLET in 1 BLISTER PACK1 blister pack2021-09-280000-00-00NoNoCurrent