Fluconazole in Sodium Chloride

Product NDC
70655-002
11-digit product format
706550002
Labeler code
70655
Product ID
70655-002_451c007f-ae60-407d-ace1-3cfc8a8b2803
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole, Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Renaissance SSA, LLC
Application
ANDA076766
Marketing category
ANDA
Marketing start
2018-09-12
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
2 mg/mL
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70655-002-062020-01-31C16284748780-19d75b9d0-e8c9-f424-e053-dadaa90a57ceFluconazole in Sodium Chloride Injection, USP
70655-002-102020-01-31C16284748780-19d75b9d0-e8c9-f424-e053-dadaa90a57ceFluconazole in Sodium Chloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70655-002-06Fluconazole in Sodium Chloride100 mL in 1 BAGINJECTION1002
70655-002-06Fluconazole in Sodium Chloride6 in 1 CARTONINJECTION62
70655-002-10Fluconazole in Sodium Chloride10 in 1 CARTONINJECTION102
70655-002-10Fluconazole in Sodium Chloride100 mL in 1 BAGINJECTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70655-002-06ML - Milliliter70655-0020bbe0457-5b9e-4945-8dd9-0cb714553be012018-12-13
70655-002-10ML - Milliliter70655-0023fb33355-d75d-478a-bc23-d75a99f2f51a12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70655-002FLUCONAZOLE IN SODIUM CHLORIDE (FLUCONAZOLE, SODIUM CHLORIDE) INJECTION [RENAISSANCE SSA, LLC]2Legacy NDC, 4 package rows20181116_caf4cccd-f295-41da-a82d-3eb02bc8e163.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721315fluconazole 200 MG in 100 ML InjectionPSNcaf4cccd-f295-41da-a82d-3eb02bc8e1632
1721314fluconazole 400 MG in 200 ML InjectionPSNcaf4cccd-f295-41da-a82d-3eb02bc8e1632
1721315100 ML fluconazole 2 MG/ML InjectionSCDcaf4cccd-f295-41da-a82d-3eb02bc8e1632
1721314200 ML fluconazole 2 MG/ML InjectionSCDcaf4cccd-f295-41da-a82d-3eb02bc8e1632
1721315fluconazole 200 MG per 100 ML InjectionSYcaf4cccd-f295-41da-a82d-3eb02bc8e1632
1721314fluconazole 400 MG per 200 ML InjectionSYcaf4cccd-f295-41da-a82d-3eb02bc8e1632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70655-002-0670655000206100 mL in 1 BAG100 mlHistorical
70655-002-107065500021010 in 1 CARTONHistorical