Fluphenazine Hydrochloride

Product NDC
90096-122
11-digit product format
900960122
Labeler code
90096
Product ID
90096-122_bba99290-dad3-4e82-960e-bf274eb5e4b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zameer Pharmaceuticals LLC
Application
ANDA215141
Marketing category
ANDA
Marketing start
2022-01-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90096-122-012024-02-13C16284748780-1f386c649-af4c-0266-e053-dadaa90a7c1aFluphenazine Hydrochloride Tablets, USP Rx only
90096-122-012023-01-30C16284748780-1f386c649-af4c-0266-e053-dadaa90a7c1aFluphenazine Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90096-122-01Fluphenazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
90096-122-01EA - Each90096-122cc46de47-f6c2-492d-b714-e298de99d64a12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90096-122FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [ZAMEER PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20241224_d9db3882-a7b5-435b-9d5a-a5e4ef7c2537.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNd9db3882-a7b5-435b-9d5a-a5e4ef7c25373
859841fluPHENAZine HCl 10 MG Oral TabletPSNd9db3882-a7b5-435b-9d5a-a5e4ef7c25373
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNd9db3882-a7b5-435b-9d5a-a5e4ef7c25373
860918fluPHENAZine HCl 5 MG Oral TabletPSNd9db3882-a7b5-435b-9d5a-a5e4ef7c25373
865117fluphenazine hydrochloride 1 MG Oral TabletSCDd9db3882-a7b5-435b-9d5a-a5e4ef7c25373
859841fluphenazine hydrochloride 10 MG Oral TabletSCDd9db3882-a7b5-435b-9d5a-a5e4ef7c25373
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDd9db3882-a7b5-435b-9d5a-a5e4ef7c25373
860918fluphenazine hydrochloride 5 MG Oral TabletSCDd9db3882-a7b5-435b-9d5a-a5e4ef7c25373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
90096-122-0190096012201100 TABLET, FILM COATED in 1 BOTTLE (90096-122-01) 2022-01-010000-00-00NoNoCurrent