fluconazole

Product NDC: 70518-3100
11-digit product format: 705183100
Labeler code: 70518
Product ID: 70518-3100_c313ee49-cafc-1d27-e053-2a95a90aa558
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208963
Marketing category: ANDA
Marketing start: 2021-05-24
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
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3100-0	2023-03-16	C162847	48780-1	f386c64a-0162-0266-e053-dadaa90a7c1a	99dbdb64-a50a-4524-8c3c-74eaf4e2678b
70518-3100-0	2023-01-30	C162847	48780-1	f386c64a-0162-0266-e053-dadaa90a7c1a	99dbdb64-a50a-4524-8c3c-74eaf4e2678b

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8VZV102JFY	FLUCONAZOLE	86386-73-4	FLUCONAZOLE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3100-0	70518310000	2 TABLET in 1 BOTTLE, PLASTIC (70518-3100-0)	2 tablet	2021-05-24	0000-00-00	No	No	Current