fluconazole

Product NDC
71205-081
11-digit product format
712050081
Labeler code
71205
Product ID
71205-081_40f55b8c-8674-413a-b58d-f1c8b767d680
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208963
Marketing category
ANDA
Marketing start
2017-04-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fluconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197699

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
71205-081-01fluconazole01 in 1 BLISTER PACKTABLET013
71205-081-02fluconazole02 in 1 BLISTER PACKTABLET023
71205-081-04fluconazole04 in 1 BLISTER PACKTABLET043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-081-01EA - Each71205-081b24adee4-5518-434f-9d3c-c77601ee561b12018-10-11
71205-081-02EA - Each71205-081f3adee92-255b-4cb0-9821-30c446774e2712018-10-11
71205-081-04EA - Each71205-0815b7db62e-1b44-420a-b413-4760daac5c5a12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-081FLUCONAZOLE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191029_7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd33
197699fluconazole 150 MG Oral TabletSCD7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-081-01712050081011 TABLET in 1 BLISTER PACK (71205-081-01) 1 tablet2018-08-010000-00-00NoNoCurrent
71205-081-02712050081022 TABLET in 1 BLISTER PACK (71205-081-02) 2 tablet2018-08-010000-00-00NoNoCurrent
71205-081-04712050081044 TABLET in 1 BLISTER PACK (71205-081-04) 4 tablet2018-08-010000-00-00NoNoCurrent