FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
0121-0654
11-digit product format
001210654
Labeler code
0121
Product ID
0121-0654_be2cdaa4-74b5-4256-90c0-e1410973b3f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
ELIXIR
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA040146
Marketing category
ANDA
Marketing start
2010-08-31
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
.5 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUPHENAZINE HYDROCHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZOU145W1XL
Rxcui859835

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
adfcae9b-bddd-ca49-dfd9-a2e8267a7d37Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0654-02Fluphenazine Hydrochloride60 mL in 1 BOTTLEELIXIR6014
0121-0654-16Fluphenazine Hydrochloride473 mL in 1 BOTTLEELIXIR47314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0654-02ML - Milliliter0121-065464dd3a3e-ae28-44b8-ad21-edca38a4a86d12012-07-24
0121-0654-16ML - Milliliter0121-06542ebd35da-dfdb-4658-b2bd-0947fd48de2b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluphenazine HydrochlorideACTIVE INGREDIENTZOU145W1XLFLUPHENAZINE HYDROCHLORIDE ELIXIR [PHARMACEUTICAL ASSOCIATES, INC.]3
FluphenazineACTIVE MOIETYS79426A41ZFLUPHENAZINE HYDROCHLORIDE ELIXIR [PHARMACEUTICAL ASSOCIATES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0654FLUPHENAZINE HYDROCHLORIDE ELIXIR [PAI HOLDINGS, LLC DBA PAI PHARMA]14Current NDC, Legacy NDC, 2 package rows20250210_f0a89d5d-01db-47f3-a873-33ab49c6e4f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859835fluPHENAZine HCl 2.5 MG in 5 mL Oral SolutionPSNf0a89d5d-01db-47f3-a873-33ab49c6e4f814
859835fluphenazine hydrochloride 0.5 MG/ML Oral SolutionSCDf0a89d5d-01db-47f3-a873-33ab49c6e4f814
859835fluphenazine HCl 2.5 MG per 5 ML Oral SolutionSYf0a89d5d-01db-47f3-a873-33ab49c6e4f814
859835fluPHENAZine HCl 2.5 MG in 5 mL Oral SolutionPSN006045b9-c22a-430a-b202-eb5cddc908ea2
859835fluphenazine hydrochloride 0.5 MG/ML Oral SolutionSCD006045b9-c22a-430a-b202-eb5cddc908ea2
859835fluphenazine HCl 2.5 MG per 5 ML Oral SolutionSY006045b9-c22a-430a-b202-eb5cddc908ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0654-020012106540260 mL in 1 BOTTLE (0121-0654-02) 60 ml2010-08-310000-00-00NoNoCurrent
0121-0654-1600121065416473 mL in 1 BOTTLE (0121-0654-16) 473 ml2010-08-310000-00-00NoNoCurrent