FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
51672-4233
11-digit product format
516724233
Labeler code
51672
Product ID
51672-4233_4db5cdb5-b848-695f-e063-6294a90a25b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA215674
Marketing category
ANDA
Marketing start
2022-04-14
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
1 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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51672-4233-12024-09-19C16284748780-11030e365-6bf2-111a-e063-dadaa90a10e2Fluphenazine Hydrochloride Tablets, USP
51672-4233-12024-01-30C16284748780-11030e365-6bf2-111a-e063-dadaa90a10e2Fluphenazine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4233-1Fluphenazine Hydrochloride1 in 1 CARTONTABLET, FILM COATED15
51672-4233-1Fluphenazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4233-1EA - Each51672-4233fa644357-b11c-4967-a410-2071f18b9e2412022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4233FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A. INC.]4Current NDC, Legacy NDC, 2 package rows20250303_7036f7c6-0792-400d-a1c7-54f21b2bd481.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSN7036f7c6-0792-400d-a1c7-54f21b2bd4815
859841fluPHENAZine HCl 10 MG Oral TabletPSN7036f7c6-0792-400d-a1c7-54f21b2bd4815
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN7036f7c6-0792-400d-a1c7-54f21b2bd4815
860918fluPHENAZine HCl 5 MG Oral TabletPSN7036f7c6-0792-400d-a1c7-54f21b2bd4815
865117fluphenazine hydrochloride 1 MG Oral TabletSCD7036f7c6-0792-400d-a1c7-54f21b2bd4815
859841fluphenazine hydrochloride 10 MG Oral TabletSCD7036f7c6-0792-400d-a1c7-54f21b2bd4815
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD7036f7c6-0792-400d-a1c7-54f21b2bd4815
860918fluphenazine hydrochloride 5 MG Oral TabletSCD7036f7c6-0792-400d-a1c7-54f21b2bd4815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4233-1516724233011 BOTTLE in 1 CARTON (51672-4233-1) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-04-140000-00-00NoNoCurrent