FLUPHENAZINE DECANOATE

Product NDC
55150-267
11-digit product format
551500267
Labeler code
55150
Product ID
55150-267_ba66703d-b81e-47da-ab6f-f8577abdce48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUPHENAZINE DECANOATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Eugia US LLC
Application
ANDA207739
Marketing category
ANDA
Marketing start
2017-10-17
Substance
FLUPHENAZINE DECANOATE
Active strength
125 mg/5mL
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 DECANOATE125 mg/5mL

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
55150-267-05FLUPHENAZINE DECANOATE5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION56
55150-267-05FLUPHENAZINE DECANOATE1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-267-05ML - Milliliter55150-26746887fa2-6e55-4c89-814f-243fca429a4312018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-267FLUPHENAZINE DECANOATE INJECTION, SOLUTION [EUGIA US LLC]5Current NDC, Legacy NDC, 2 package rows20241121_1f532edc-1a2c-4221-80dd-1ac158dd3a72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859824fluPHENAZine decanoate 25 MG/ML Injectable SolutionPSN1f532edc-1a2c-4221-80dd-1ac158dd3a726
859824fluphenazine decanoate 25 MG/ML Injectable SolutionSCD1f532edc-1a2c-4221-80dd-1ac158dd3a726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-267-05551500267051 VIAL, MULTI-DOSE in 1 CARTON (55150-267-05) / 5 mL in 1 VIAL, MULTI-DOSE2017-10-170000-00-00NoNoCurrent