FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
50268-366
11-digit product format
502680366
Labeler code
50268
Product ID
50268-366_2b4993c9-b528-9f47-e063-6394a90a7a4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA214534
Marketing category
ANDA
Marketing start
2022-07-06
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
Rxcui860918, 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
50268-366-11Fluphenazine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-366-15Fluphenazine Hydrochloride50 in 1 BOXTABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-366-11EA - Each50268-36635b0e4a5-5003-4c0e-be63-55a8c8d4c51f12022-08-04
50268-366-15EA - Each50268-36684a7c4a7-8afb-4169-8595-56ed0dc873ae12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-366FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]2Current NDC, Legacy NDC, 2 package rows20250112_e3277017-1d58-7105-e053-2995a90a9255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNe3277017-1d58-7105-e053-2995a90a92552
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNe3277017-1d58-7105-e053-2995a90a92552
860918fluPHENAZine HCl 5 MG Oral TabletPSNe3277017-1d58-7105-e053-2995a90a92552
865117fluphenazine hydrochloride 1 MG Oral TabletSCDe3277017-1d58-7105-e053-2995a90a92552
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDe3277017-1d58-7105-e053-2995a90a92552
860918fluphenazine hydrochloride 5 MG Oral TabletSCDe3277017-1d58-7105-e053-2995a90a92552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-366-11502680366111 in 1 BLISTER PACKHistorical
50268-366-155026803661550 BLISTER PACK in 1 BOX (50268-366-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-366-11) 50 blister pack2022-07-060000-00-00NoNoCurrent