FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
63323-281
11-digit product format
633230281
Labeler code
63323
Product ID
63323-281_cefdb059-d32b-44f2-8dd6-fd2a29b3ba70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUPHENAZINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Fresenius Kabi USA, LLC
Application
ANDA089556
Marketing category
ANDA
Marketing start
2010-12-28
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
2.5 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 HYDROCHLORIDE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZOU145W1XL
Rxcui865129

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
63323-281-10Fluphenazine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION104
63323-281-10Fluphenazine Hydrochloride1 in 1 BOXINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-281-10ML - Milliliter63323-281a5d4745c-e4c4-4713-92e4-7922a6555de412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUPHENAZINE HYDROCHLORIDEACTIVE INGREDIENTZOU145W1XLFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
FLUPHENAZINEACTIVE MOIETYS79426A41ZFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
FLUPHENAZINE HYDROCHLORIDEACTIVE INGREDIENTZOU145W1XLFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
FLUPHENAZINEACTIVE MOIETYS79426A41ZFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-281FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20241019_d571f04f-6190-42f2-932c-5a075fd978b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865129fluPHENAZine HCl 2.5 MG/ML Injectable SolutionPSNd571f04f-6190-42f2-932c-5a075fd978b94
865129fluphenazine hydrochloride 2.5 MG/ML Injectable SolutionSCDd571f04f-6190-42f2-932c-5a075fd978b94
865129fluphenazine HCl 2.5 MG/ML Injectable SolutionSYd571f04f-6190-42f2-932c-5a075fd978b94
865129fluPHENAZine HCl 2.5 MG/ML Injectable SolutionPSN2a8ef5f7-c806-470d-96ff-3b3827dc89382
865129fluphenazine hydrochloride 2.5 MG/ML Injectable SolutionSCD2a8ef5f7-c806-470d-96ff-3b3827dc89382
865129fluphenazine HCl 2.5 MG/ML Injectable SolutionSY2a8ef5f7-c806-470d-96ff-3b3827dc89382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-281-10633230281101 VIAL in 1 BOX (63323-281-10) / 10 mL in 1 VIAL1 vial2010-12-280000-00-00NoNoCurrent