Fluphenazine Hydrochloride

Product NDC
0904-7160
11-digit product format
009047160
Labeler code
0904
Product ID
0904-7160_491d902d-1778-4bd3-a836-d1faf6ea9930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA089743
Marketing category
ANDA
Marketing start
1988-08-25
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
0904-7160-61Fluphenazine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED14
0904-7160-61Fluphenazine Hydrochloride100 in 1 CARTONTABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7160-61EA - Each0904-71604ded45a9-af25-4038-8c9e-04520180f7dd12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7160FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20250101_e8d4065a-45fc-4adf-9406-2122ca131d99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNe8d4065a-45fc-4adf-9406-2122ca131d994
859841fluPHENAZine HCl 10 MG Oral TabletPSNe8d4065a-45fc-4adf-9406-2122ca131d994
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNe8d4065a-45fc-4adf-9406-2122ca131d994
860918fluPHENAZine HCl 5 MG Oral TabletPSNe8d4065a-45fc-4adf-9406-2122ca131d994
865117fluphenazine hydrochloride 1 MG Oral TabletSCDe8d4065a-45fc-4adf-9406-2122ca131d994
859841fluphenazine hydrochloride 10 MG Oral TabletSCDe8d4065a-45fc-4adf-9406-2122ca131d994
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDe8d4065a-45fc-4adf-9406-2122ca131d994
860918fluphenazine hydrochloride 5 MG Oral TabletSCDe8d4065a-45fc-4adf-9406-2122ca131d994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7160-6100904716061100 BLISTER PACK in 1 CARTON (0904-7160-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack1988-08-250000-00-00NoNoCurrent