fluphenazine hydrochloride

Product NDC
62135-416
11-digit product format
621350416
Labeler code
62135
Product ID
62135-416_458c6457-ed15-15f4-e063-6294a90acc6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluphenazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA215141
Marketing category
ANDA
Marketing start
2022-01-01
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
2.5 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 HYDROCHLORIDE2.5 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
62135-416-90fluphenazine hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-416-90EA - Each62135-416908dd40e-0a20-46c3-9e13-c24f62cf3d7312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-416FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 1 package rows20241030_325af2a4-2280-4236-8cf8-44f5700ba73f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSN325af2a4-2280-4236-8cf8-44f5700ba73f4
859841fluPHENAZine HCl 10 MG Oral TabletPSN325af2a4-2280-4236-8cf8-44f5700ba73f4
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN325af2a4-2280-4236-8cf8-44f5700ba73f4
860918fluPHENAZine HCl 5 MG Oral TabletPSN325af2a4-2280-4236-8cf8-44f5700ba73f4
865117fluphenazine hydrochloride 1 MG Oral TabletSCD325af2a4-2280-4236-8cf8-44f5700ba73f4
859841fluphenazine hydrochloride 10 MG Oral TabletSCD325af2a4-2280-4236-8cf8-44f5700ba73f4
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD325af2a4-2280-4236-8cf8-44f5700ba73f4
860918fluphenazine hydrochloride 5 MG Oral TabletSCD325af2a4-2280-4236-8cf8-44f5700ba73f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-416-906213504169090 TABLET, FILM COATED in 1 BOTTLE (62135-416-90) 2022-10-200000-00-00NoNoCurrent