FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
62332-790
11-digit product format
623320790
Labeler code
62332
Product ID
62332-790_f7ef2923-6d2a-4b1f-ad9c-c8127391b9f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA218173
Marketing category
ANDA
Marketing start
2024-07-25
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
62332-790-31Fluphenazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
62332-790-71Fluphenazine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-790-31EA - Each62332-790b93b5a31-0139-4e2a-a414-1bd0816b252e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-790FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, 2 package rows20250112_1991be2c-9629-4c3e-93f0-e40bcffc82b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSN1991be2c-9629-4c3e-93f0-e40bcffc82b05
859841fluPHENAZine HCl 10 MG Oral TabletPSN1991be2c-9629-4c3e-93f0-e40bcffc82b05
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN1991be2c-9629-4c3e-93f0-e40bcffc82b05
860918fluPHENAZine HCl 5 MG Oral TabletPSN1991be2c-9629-4c3e-93f0-e40bcffc82b05
865117fluphenazine hydrochloride 1 MG Oral TabletSCD1991be2c-9629-4c3e-93f0-e40bcffc82b05
859841fluphenazine hydrochloride 10 MG Oral TabletSCD1991be2c-9629-4c3e-93f0-e40bcffc82b05
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD1991be2c-9629-4c3e-93f0-e40bcffc82b05
860918fluphenazine hydrochloride 5 MG Oral TabletSCD1991be2c-9629-4c3e-93f0-e40bcffc82b05
860918fluPHENAZine HCl 5 MG Oral TabletPSN325c8c34-2858-af36-e063-6394a90a78141
860918fluphenazine hydrochloride 5 MG Oral TabletSCD325c8c34-2858-af36-e063-6394a90a78141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-790-3162332079031100 TABLET, FILM COATED in 1 BOTTLE (62332-790-31) 2024-07-25NoNoCurrent
62332-790-7162332079071500 TABLET, FILM COATED in 1 BOTTLE (62332-790-71) 2024-07-25NoNoCurrent