Fluphenazine Hydrochloride

Product NDC
46708-788
11-digit product format
467080788
Labeler code
46708
Product ID
46708-788_7c29fb1f-9403-4e55-abd9-36adfb152e8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA218173
Marketing category
ANDA
Marketing start
2024-07-25
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
1 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 HYDROCHLORIDE1 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
46708-788-31Fluphenazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
46708-788-71Fluphenazine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-788FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20240727_7c29fb1f-9403-4e55-abd9-36adfb152e8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSN7c29fb1f-9403-4e55-abd9-36adfb152e8e1
859841fluPHENAZine HCl 10 MG Oral TabletPSN7c29fb1f-9403-4e55-abd9-36adfb152e8e1
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN7c29fb1f-9403-4e55-abd9-36adfb152e8e1
860918fluPHENAZine HCl 5 MG Oral TabletPSN7c29fb1f-9403-4e55-abd9-36adfb152e8e1
865117fluphenazine hydrochloride 1 MG Oral TabletSCD7c29fb1f-9403-4e55-abd9-36adfb152e8e1
859841fluphenazine hydrochloride 10 MG Oral TabletSCD7c29fb1f-9403-4e55-abd9-36adfb152e8e1
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD7c29fb1f-9403-4e55-abd9-36adfb152e8e1
860918fluphenazine hydrochloride 5 MG Oral TabletSCD7c29fb1f-9403-4e55-abd9-36adfb152e8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-788-3146708078831100 TABLET, FILM COATED in 1 BOTTLE (46708-788-31) 2024-07-25NoNoHistorical
46708-788-7146708078871500 TABLET, FILM COATED in 1 BOTTLE (46708-788-71) 2024-07-25NoNoHistorical