fluconazole

Product NDC
70710-1140
11-digit product format
707101140
Labeler code
70710
Product ID
70710-1140_538304da-3971-4e3d-9ad3-af8b3dc186c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA208963
Marketing category
ANDA
Marketing start
2017-04-06
Substance
FLUCONAZOLE
Active strength
200 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fluconazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197699, 197700, 197701

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1140-1fluconazole100 in 1 BOTTLETABLET10013
70710-1140-3fluconazole30 in 1 BOTTLETABLET3013
70710-1140-4fluconazole10 in 1 BLISTER PACKTABLET1013
70710-1140-4fluconazole10 in 1 CARTONTABLET1013
70710-1140-5fluconazole500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1140-1EA - Each70710-1140661b5f73-5fe3-425b-8a7f-c5c384fc210412018-02-20
70710-1140-3EA - Each70710-1140f43ad117-c887-4f28-851a-6e9aea4c970f12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
povidoneINACTIVE INGREDIENTFZ989GH94EDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1140FLUCONAZOLE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]12Current NDC, Legacy NDC, 5 package rows20240306_d1364455-1537-46d4-b093-38cca3be778f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSN7259671f-a703-4a2a-81db-9a4839b34072103
197700fluconazole 200 MG Oral TabletSCD7259671f-a703-4a2a-81db-9a4839b34072103
197698fluconazole 100 MG Oral TabletPSNd1364455-1537-46d4-b093-38cca3be778f13
197699fluconazole 150 MG Oral TabletPSNd1364455-1537-46d4-b093-38cca3be778f13
197700fluconazole 200 MG Oral TabletPSNd1364455-1537-46d4-b093-38cca3be778f13
197701fluconazole 50 MG Oral TabletPSNd1364455-1537-46d4-b093-38cca3be778f13
197698fluconazole 100 MG Oral TabletSCDd1364455-1537-46d4-b093-38cca3be778f13
197699fluconazole 150 MG Oral TabletSCDd1364455-1537-46d4-b093-38cca3be778f13
197700fluconazole 200 MG Oral TabletSCDd1364455-1537-46d4-b093-38cca3be778f13
197701fluconazole 50 MG Oral TabletSCDd1364455-1537-46d4-b093-38cca3be778f13
197700fluconazole 200 MG Oral TabletPSN69f199fa-bb92-4837-8b12-427a1c71f6226
197700fluconazole 200 MG Oral TabletSCD69f199fa-bb92-4837-8b12-427a1c71f6226
197700fluconazole 200 MG Oral TabletPSN7961c029-746c-48c3-888b-8f83441028733
197700fluconazole 200 MG Oral TabletSCD7961c029-746c-48c3-888b-8f83441028733
197700fluconazole 200 MG Oral TabletPSNf232600e-70ce-4001-b9da-31442f0920b92
197700fluconazole 200 MG Oral TabletSCDf232600e-70ce-4001-b9da-31442f0920b92
197700fluconazole 200 MG Oral TabletPSNd4b2e102-9b2c-17c9-e053-2995a90a06d11
197700fluconazole 200 MG Oral TabletPSN1fc0d542-ec85-85fb-e063-6294a90a17021
197700fluconazole 200 MG Oral TabletSCD1fc0d542-ec85-85fb-e063-6294a90a17021
197700fluconazole 200 MG Oral TabletSCDd4b2e102-9b2c-17c9-e053-2995a90a06d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1140-170710114001100 TABLET in 1 BOTTLE (70710-1140-1) 100 tablet2017-04-060000-00-00NoNoCurrent
70710-1140-37071011400330 TABLET in 1 BOTTLE (70710-1140-3) 30 tablet2017-04-060000-00-00NoNoCurrent
70710-1140-47071011400410 BLISTER PACK in 1 CARTON (70710-1140-4) / 10 TABLET in 1 BLISTER PACK10 blister pack2017-04-060000-00-00NoNoCurrent
70710-1140-570710114005500 TABLET in 1 BOTTLE (70710-1140-5) 500 tablet2017-04-060000-00-00NoNoCurrent