Fluconazole

Product NDC
16571-213
11-digit product format
165710213
Labeler code
16571
Product ID
16571-213_c6266a40-1ceb-4dec-adc2-a118db7cd6e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA076957
Marketing category
ANDA
Marketing start
2014-03-25
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
200 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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-213-10EA - Each16571-2133d55e180-6327-4c1f-a6c0-668a73b1ef9112014-05-02
16571-213-30EA - Each16571-213430ea266-6c85-4ab8-865b-8ea8dba33e6912014-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-213-1016571021310100 TABLET in 1 BOTTLE (16571-213-10) 100 tablet2014-03-250000-00-00NoNoCurrent
16571-213-301657102133030 TABLET in 1 BOTTLE (16571-213-30) 30 tablet2014-03-250000-00-00NoNoCurrent