Fluphenazine Hydrochloride

Product NDC
67046-1547
11-digit product format
670461547
Labeler code
67046
Product ID
67046-1547_325c8a4a-a623-015f-e063-6294a90a92e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA218173
Marketing category
ANDA
Marketing start
2025-04-09
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUPHENAZINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZOU145W1XL
Rxcui860918

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
67046-1547-3Fluphenazine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1547FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [COUPLER LLC]1Current NDC, 1 package rows20250410_325c8c34-2858-af36-e063-6394a90a7814.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860918fluPHENAZine HCl 5 MG Oral TabletPSN325c8c34-2858-af36-e063-6394a90a78141
860918fluphenazine hydrochloride 5 MG Oral TabletSCD325c8c34-2858-af36-e063-6394a90a78141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1547-36704615470330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1547-3) 2025-04-09NoNoHistorical