FDA.reportPublic FDA data

Fluphenazine Hydrochoride

Product NDC
16571-891
11-digit product format
165710891
Labeler code
16571
Product ID
16571-891_5e7076f6-426b-45c2-865f-7be79fe81205
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluphenazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA218283
Marketing category
ANDA
Marketing start
2024-06-07
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 Hydrochoride
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
16571-891-09Fluphenazine Hydrochoride90 in 1 CONTAINERTABLET, FILM COATED906
16571-891-50Fluphenazine Hydrochoride500 in 1 CONTAINERTABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-891-09EA - Each16571-891bd0b376a-a4df-464b-b834-0a20583962aa12025-02-10
16571-891-50EA - Each16571-89126ef90e1-ab03-41e2-b849-2949f2b1887112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-891FLUPHENAZINE HYDROCHORIDE (FLUPHENAZINE HYDROCHLORIDE) TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]4Current NDC, 2 package rows20250129_9fd44ab9-79bb-472e-8434-c3d786b42de5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSN9fd44ab9-79bb-472e-8434-c3d786b42de56
859841fluPHENAZine HCl 10 MG Oral TabletPSN9fd44ab9-79bb-472e-8434-c3d786b42de56
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN9fd44ab9-79bb-472e-8434-c3d786b42de56
860918fluPHENAZine HCl 5 MG Oral TabletPSN9fd44ab9-79bb-472e-8434-c3d786b42de56
865117fluphenazine hydrochloride 1 MG Oral TabletSCD9fd44ab9-79bb-472e-8434-c3d786b42de56
859841fluphenazine hydrochloride 10 MG Oral TabletSCD9fd44ab9-79bb-472e-8434-c3d786b42de56
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD9fd44ab9-79bb-472e-8434-c3d786b42de56
860918fluphenazine hydrochloride 5 MG Oral TabletSCD9fd44ab9-79bb-472e-8434-c3d786b42de56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-891-091657108910990 TABLET, FILM COATED in 1 CONTAINER (16571-891-09) 2024-06-07NoNoHistorical
16571-891-5016571089150500 TABLET, FILM COATED in 1 CONTAINER (16571-891-50) 2024-06-07NoNoHistorical