Fluphenazine Decanoate

Product NDC
0143-9529
11-digit product format
001439529
Labeler code
0143
Product ID
0143-9529_d4bda611-29b9-4148-90ca-5783cce391df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074531
Marketing category
ANDA
Marketing start
1996-08-30
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
0143-9529-01Fluphenazine Decanoate1 in 1 BOXINJECTION17
0143-9529-01Fluphenazine Decanoate5 mL in 1 VIAL, MULTI-DOSEINJECTION57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9529-01ML - Milliliter0143-9529c599a2d3-ac1d-48e8-90cf-9a531e9371d212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9529FLUPHENAZINE DECANOATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250130_1967dc24-f2a5-4095-baa9-a9d1c5410311.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859824fluPHENAZine decanoate 25 MG/ML Injectable SolutionPSN1967dc24-f2a5-4095-baa9-a9d1c54103117
859824fluphenazine decanoate 25 MG/ML Injectable SolutionSCD1967dc24-f2a5-4095-baa9-a9d1c54103117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9529-01001439529011 VIAL, MULTI-DOSE in 1 BOX (0143-9529-01) / 5 mL in 1 VIAL, MULTI-DOSE1996-08-300000-00-00NoNoCurrent