Fluphenazine Hydrochloride

Product NDC
59651-689
11-digit product format
596510689
Labeler code
59651
Product ID
59651-689_1109b107-f7af-45b7-b8ee-709c59123074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218055
Marketing category
ANDA
Marketing start
2023-08-18
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
10 mg/1
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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZOU145W1XL
Rxcui859841, 860918, 865117, 865123

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
59651-689-01Fluphenazine Hydrochloride100 in 1 BOTTLETABLET1003
59651-689-05Fluphenazine Hydrochloride500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-689-01EA - Each59651-689684324c2-b79d-4196-8e67-98e4bf7a15d312024-02-14
59651-689-05EA - Each59651-6890021dbe0-366a-4b30-b6d2-4e38fc2fa9ca12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-689FLUPHENAZINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]3Current NDC, 2 package rows20241121_e73764e7-e666-4ad3-a029-04a528dc1c9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNe73764e7-e666-4ad3-a029-04a528dc1c9e3
859841fluPHENAZine HCl 10 MG Oral TabletPSNe73764e7-e666-4ad3-a029-04a528dc1c9e3
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNe73764e7-e666-4ad3-a029-04a528dc1c9e3
860918fluPHENAZine HCl 5 MG Oral TabletPSNe73764e7-e666-4ad3-a029-04a528dc1c9e3
865117fluphenazine hydrochloride 1 MG Oral TabletSCDe73764e7-e666-4ad3-a029-04a528dc1c9e3
859841fluphenazine hydrochloride 10 MG Oral TabletSCDe73764e7-e666-4ad3-a029-04a528dc1c9e3
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDe73764e7-e666-4ad3-a029-04a528dc1c9e3
860918fluphenazine hydrochloride 5 MG Oral TabletSCDe73764e7-e666-4ad3-a029-04a528dc1c9e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-689-0159651068901100 TABLET in 1 BOTTLE (59651-689-01) 100 tablet2023-08-18NoNoHistorical
59651-689-0559651068905500 TABLET in 1 BOTTLE (59651-689-05) 500 tablet2023-08-18NoNoHistorical