Fluphenazine Hydrochloride

Product NDC
70771-1583
11-digit product format
707711583
Labeler code
70771
Product ID
70771-1583_1db40261-ae57-4539-a7e9-7ca75d96627a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA214552
Marketing category
ANDA
Marketing start
2021-05-28
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
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
70771-1583-1Fluphenazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003
70771-1583-5Fluphenazine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1583FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 2 package rows20241207_977dc369-6b6d-4ad1-9239-a46f63a764bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSN977dc369-6b6d-4ad1-9239-a46f63a764bd3
859841fluPHENAZine HCl 10 MG Oral TabletPSN977dc369-6b6d-4ad1-9239-a46f63a764bd3
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN977dc369-6b6d-4ad1-9239-a46f63a764bd3
860918fluPHENAZine HCl 5 MG Oral TabletPSN977dc369-6b6d-4ad1-9239-a46f63a764bd3
865117fluphenazine hydrochloride 1 MG Oral TabletSCD977dc369-6b6d-4ad1-9239-a46f63a764bd3
859841fluphenazine hydrochloride 10 MG Oral TabletSCD977dc369-6b6d-4ad1-9239-a46f63a764bd3
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD977dc369-6b6d-4ad1-9239-a46f63a764bd3
860918fluphenazine hydrochloride 5 MG Oral TabletSCD977dc369-6b6d-4ad1-9239-a46f63a764bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1583-170771158301100 TABLET, FILM COATED in 1 BOTTLE (70771-1583-1) 2021-05-280000-00-00NoNoCurrent
70771-1583-570771158305500 TABLET, FILM COATED in 1 BOTTLE (70771-1583-5) 2021-05-280000-00-00NoNoCurrent