fluconazole

Product NDC
68788-7888
11-digit product format
687887888
Labeler code
68788
Product ID
68788-7888_ec5aaed6-29ab-48ce-8ae3-7c6def1222ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208963
Marketing category
ANDA
Marketing start
2021-04-16
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 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7888-1EA - Each68788-78886733799d-203e-4621-98fa-e4d28399688412021-06-02
68788-7888-2EA - Each68788-78888bc5d2b8-b226-4155-9f64-1270d19a6dab12021-06-02
68788-7888-8EA - Each68788-7888e46b3110-f7a0-4f5f-926c-73074e11304b12021-06-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7888-1687887888011 TABLET in 1 BOTTLE (68788-7888-1) 1 tablet2021-04-160000-00-00NoNoCurrent
68788-7888-2687887888022 TABLET in 1 BOTTLE (68788-7888-2) 2 tablet2021-04-160000-00-00NoNoCurrent
68788-7888-86878878880812 TABLET in 1 BOTTLE (68788-7888-8) 12 tablet2021-04-160000-00-00NoNoCurrent