Fluphenazine Decanoate

Product NDC
72205-100
11-digit product format
722050100
Labeler code
72205
Product ID
72205-100_10660418-e3a4-455b-bf84-add1f409ec16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Decanoate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215365
Marketing category
ANDA
Marketing start
2023-11-02
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
72205-100-01Fluphenazine Decanoate1 in 1 CARTONINJECTION, SOLUTION13
72205-100-01Fluphenazine Decanoate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-100-01ML - Milliliter72205-100a16a7171-a3bc-4bde-af1a-9b70e72884ef12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-100FLUPHENAZINE DECANOATE INJECTION, SOLUTION [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, 2 package rows20250322_8d7ba627-cf3f-4b94-aee8-8b44cc9400be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859824fluPHENAZine decanoate 25 MG/ML Injectable SolutionPSN044f49f3-f980-4ef8-8beb-78412702cd9d100
859824fluphenazine decanoate 25 MG/ML Injectable SolutionSCD044f49f3-f980-4ef8-8beb-78412702cd9d100
859824fluPHENAZine decanoate 25 MG/ML Injectable SolutionPSN8d7ba627-cf3f-4b94-aee8-8b44cc9400be3
859824fluphenazine decanoate 25 MG/ML Injectable SolutionSCD8d7ba627-cf3f-4b94-aee8-8b44cc9400be3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-100-01722050100011 VIAL, MULTI-DOSE in 1 CARTON (72205-100-01) / 5 mL in 1 VIAL, MULTI-DOSE2023-11-23NoNoCurrent