Fluphenazine Decanoate

Product NDC
67457-359
11-digit product format
674570359
Labeler code
67457
Product ID
67457-359_08baa8e5-a317-4529-9b2b-9a9c2ba5e7ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUPHENAZINE DECANOATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
ANDA075918
Marketing category
ANDA
Marketing start
2018-09-28
Substance
FLUPHENAZINE DECANOATE
Active strength
25 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUPHENAZINE DECANOATE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFMU62K1L3C
Rxcui859824

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4255c821-309e-3e59-d8e2-48974bad3552Product name820250626
817a13b7-685c-6d80-08bc-347c9a7530c4Product name420240419
817a13b7-685c-6d80-08bc-347c9a7530c4Product name320171211
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
adfcae9b-bddd-ca49-dfd9-a2e8267a7d37Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-359-59Fluphenazine Decanoate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION56
67457-359-59Fluphenazine Decanoate1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-359-59ML - Milliliter67457-359e7bf0c6c-0c26-419a-8769-85de13a6efe912018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-359FLUPHENAZINE DECANOATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6Current NDC, Legacy NDC, 2 package rows20241127_3832d3d3-15ce-4d41-8431-11e9bd04cf4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859824fluPHENAZine decanoate 25 MG/ML Injectable SolutionPSN3832d3d3-15ce-4d41-8431-11e9bd04cf4d6
859824fluphenazine decanoate 25 MG/ML Injectable SolutionSCD3832d3d3-15ce-4d41-8431-11e9bd04cf4d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-359-59674570359591 VIAL, MULTI-DOSE in 1 CARTON (67457-359-59) / 5 mL in 1 VIAL, MULTI-DOSE2018-09-280000-00-00NoNoCurrent