Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Unique Pharmaceutical Laboratories
Drug Ocean LLC
650434645
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluconazole
Product Details
NDC Product Code
70985-013Application Number
ANDA076957Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 30, 2023ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 50 mg in 1 1
Fluconazole
Product Details
NDC Product Code
70985-016Application Number
ANDA076957Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 30, 2023CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 200 mg in 1 1
Fluconazole
Product Details
NDC Product Code
70985-015Application Number
ANDA076957Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 30, 2023CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 150 mg in 1 1
Fluconazole
Product Details
NDC Product Code
70985-014Application Number
ANDA076957Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 30, 2023CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 100 mg in 1 1