Fluphenazine Hydrochloride

Product NDC
70710-1488
11-digit product format
707101488
Labeler code
70710
Product ID
70710-1488_130b45fa-6dbd-46cc-a937-ab8ef1ec0718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA214552
Marketing category
ANDA
Marketing start
2021-05-28
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
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
70710-1488-1Fluphenazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
70710-1488-5Fluphenazine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1488-1EA - Each70710-1488147e291b-c2fa-4e98-9069-c911eb72c57112021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1488FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 2 package rows20241207_c4448579-3ccb-442e-8950-a219d1f01a98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNc4448579-3ccb-442e-8950-a219d1f01a984
859841fluPHENAZine HCl 10 MG Oral TabletPSNc4448579-3ccb-442e-8950-a219d1f01a984
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNc4448579-3ccb-442e-8950-a219d1f01a984
860918fluPHENAZine HCl 5 MG Oral TabletPSNc4448579-3ccb-442e-8950-a219d1f01a984
865117fluphenazine hydrochloride 1 MG Oral TabletSCDc4448579-3ccb-442e-8950-a219d1f01a984
859841fluphenazine hydrochloride 10 MG Oral TabletSCDc4448579-3ccb-442e-8950-a219d1f01a984
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDc4448579-3ccb-442e-8950-a219d1f01a984
860918fluphenazine hydrochloride 5 MG Oral TabletSCDc4448579-3ccb-442e-8950-a219d1f01a984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1488-170710148801100 TABLET, FILM COATED in 1 BOTTLE (70710-1488-1) 2021-05-280000-00-00NoNoCurrent
70710-1488-570710148805500 TABLET, FILM COATED in 1 BOTTLE (70710-1488-5) 2021-05-280000-00-00NoNoCurrent