Fluphenazine Decanoate

Product NDC
72162-2635
11-digit product format
721622635
Labeler code
72162
Product ID
72162-2635_226377ed-4d32-4880-b283-1036c2d1d740
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Decanoate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Bryant Ranch Prepack
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluphenazine Decanoate
Listing expiration
2027-12-31

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
72162-2635-2Fluphenazine Decanoate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5100
72162-2635-2Fluphenazine Decanoate1 in 1 CARTONINJECTION, SOLUTION1100

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2635-2721622635021 VIAL, MULTI-DOSE in 1 CARTON (72162-2635-2) / 5 mL in 1 VIAL, MULTI-DOSE2026-05-06NoNoHistorical