Fluphenazine Hydrochloride

Product NDC
31722-385
11-digit product format
317220385
Labeler code
31722
Product ID
31722-385_4468c081-e6a4-bbbf-e063-6294a90aa886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218769
Marketing category
ANDA
Marketing start
2025-11-18
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
2.5 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 HYDROCHLORIDE2.5 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
31722-385-01Fluphenazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
31722-385-05Fluphenazine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSN4dd61338-8e4b-41c6-99d8-811a8e990c4e1
859841fluPHENAZine HCl 10 MG Oral TabletPSN4dd61338-8e4b-41c6-99d8-811a8e990c4e1
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN4dd61338-8e4b-41c6-99d8-811a8e990c4e1
860918fluPHENAZine HCl 5 MG Oral TabletPSN4dd61338-8e4b-41c6-99d8-811a8e990c4e1
865117fluphenazine hydrochloride 1 MG Oral TabletSCD4dd61338-8e4b-41c6-99d8-811a8e990c4e1
859841fluphenazine hydrochloride 10 MG Oral TabletSCD4dd61338-8e4b-41c6-99d8-811a8e990c4e1
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD4dd61338-8e4b-41c6-99d8-811a8e990c4e1
860918fluphenazine hydrochloride 5 MG Oral TabletSCD4dd61338-8e4b-41c6-99d8-811a8e990c4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-385-0131722038501100 TABLET, FILM COATED in 1 BOTTLE (31722-385-01) 2025-11-18NoNoCurrent
31722-385-0531722038505500 TABLET, FILM COATED in 1 BOTTLE (31722-385-05) 2025-11-18NoNoCurrent