Fluphenazine Decanoate

Product NDC
25021-838
11-digit product format
250210838
Labeler code
25021
Product ID
25021-838_bd85ef0f-3c47-4d48-9ba0-9d4e012698cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Decanoate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA215509
Marketing category
ANDA
Marketing start
2023-08-01
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
25021-838-05Fluphenazine Decanoate5 mL in 1 VIALINJECTION, SOLUTION51
25021-838-05Fluphenazine Decanoate1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-838FLUPHENAZINE DECANOATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20230801_1842a678-c32b-4e81-998e-597fc370fb9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859824fluPHENAZine decanoate 25 MG/ML Injectable SolutionPSN1842a678-c32b-4e81-998e-597fc370fb9e1
859824fluphenazine decanoate 25 MG/ML Injectable SolutionSCD1842a678-c32b-4e81-998e-597fc370fb9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-838-05250210838051 VIAL in 1 CARTON (25021-838-05) / 5 mL in 1 VIAL1 vial2023-08-01NoNoHistorical