Fluphenazine Hydrochloride

Product NDC
64725-1438
11-digit product format
647251438
Labeler code
64725
Product ID
64725-1438_1069b2e7-e199-4a74-aa49-19a754d3b70d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA089586
Marketing category
ANDA
Marketing start
1987-10-16
Marketing end
0000-00-00
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-1438-12019-11-27C16284748780-19855e2a2-38e5-60a7-e053-dbdaa90a05bdFluphenazine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-1438-1Fluphenazine Hydrochloride100 in 1 CONTAINERTABLET, FILM COATED1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUPHENAZINE HYDROCHLORIDEACTIVE INGREDIENTZOU145W1XLFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FLUPHENAZINEACTIVE MOIETYS79426A41ZFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-1438FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140901_50c7e742-1165-4c45-bbf6-172cf70a387a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860918fluPHENAZine HCl 5 MG Oral TabletPSN50c7e742-1165-4c45-bbf6-172cf70a387a2
860918fluphenazine hydrochloride 5 MG Oral TabletSCD50c7e742-1165-4c45-bbf6-172cf70a387a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-1438-164725143801100 in 1 CONTAINERHistorical