Fluconazole

Product NDC
16571-212
11-digit product format
165710212
Labeler code
16571
Product ID
16571-212_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
2017-03-01
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16571-212-122024-02-22C16284748780-11030e365-5824-111a-e063-dadaa90a10e24f9743dc-2040-43ed-a961-62f4810a3f78
16571-212-122024-01-30C16284748780-11030e365-5824-111a-e063-dadaa90a10e24f9743dc-2040-43ed-a961-62f4810a3f78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-212-12165710212121 TABLET in 1 PACKAGE (16571-212-12) 1 tablet2017-03-010000-00-00NoNoCurrent