Fluphenazine hydrochloride

Product NDC
70518-4273
11-digit product format
705184273
Labeler code
70518
Product ID
70518-4273_5025ebc2-a290-192f-e063-6294a90a0bce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217410
Marketing category
ANDA
Marketing start
2025-02-03
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluphenazine hydrochloride
Listing expiration
2027-12-31

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
70518-4273-0Fluphenazine hydrochloride30 in 1 BLISTER PACKTABLET304
70518-4273-1Fluphenazine hydrochloride50 in 1 BOXTABLET504
70518-4273-2Fluphenazine hydrochloride1 in 1 POUCHTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4273FLUPHENAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 3 package rows20250423_85720b55-3419-4e2c-95dd-22eec035d6f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860918fluPHENAZine HCl 5 MG Oral TabletPSN85720b55-3419-4e2c-95dd-22eec035d6f14
860918fluphenazine hydrochloride 5 MG Oral TabletSCD85720b55-3419-4e2c-95dd-22eec035d6f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4273-07051842730030 TABLET in 1 BLISTER PACK (70518-4273-0) 30 tablet2025-02-03NoNoHistorical
70518-4273-17051842730150 POUCH in 1 BOX (70518-4273-1) / 1 TABLET in 1 POUCH (70518-4273-2) 50 pouch2026-04-23NoNoHistorical
70518-4273-2705184273021 in 1 POUCHHistorical