Fluconazole

Product NDC
55700-521
11-digit product format
557000521
Labeler code
55700
Product ID
55700-521_3b5e21d1-25be-4a3b-9829-8cc112ddd36f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078423
Marketing category
ANDA
Marketing start
2017-02-24
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
55700-521-012025-01-09C16284748780-1f386c649-dd7d-0266-e053-dadaa90a7c1a2b0838e4-80e0-4bdf-9cdb-e596fd1436f9
55700-521-012023-01-30C16284748780-1f386c649-dd7d-0266-e053-dadaa90a7c1a2b0838e4-80e0-4bdf-9cdb-e596fd1436f9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-521-01EA - Each55700-521a2f79348-b512-442f-9a9d-9ce5f395a6b312017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-521-01557000521011 TABLET in 1 BLISTER PACK (55700-521-01) 1 tablet2017-05-050000-00-00NoNoCurrent