fluphenazine hydrochloride

Product NDC
69238-1678
11-digit product format
692381678
Labeler code
69238
Product ID
69238-1678_e350dbeb-6212-43b1-8c85-f60fb1719e0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluphenazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA213647
Marketing category
ANDA
Marketing start
2020-07-11
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1678-1fluphenazine hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1678-1EA - Each69238-16786024a85e-c97d-4519-b269-c7855602810412021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1678FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 1 package rows20231231_5b443b30-5682-4cf3-9ed0-716efddbc865.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSN5b443b30-5682-4cf3-9ed0-716efddbc86513
859841fluPHENAZine HCl 10 MG Oral TabletPSN5b443b30-5682-4cf3-9ed0-716efddbc86513
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN5b443b30-5682-4cf3-9ed0-716efddbc86513
860918fluPHENAZine HCl 5 MG Oral TabletPSN5b443b30-5682-4cf3-9ed0-716efddbc86513
865117fluphenazine hydrochloride 1 MG Oral TabletSCD5b443b30-5682-4cf3-9ed0-716efddbc86513
859841fluphenazine hydrochloride 10 MG Oral TabletSCD5b443b30-5682-4cf3-9ed0-716efddbc86513
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD5b443b30-5682-4cf3-9ed0-716efddbc86513
860918fluphenazine hydrochloride 5 MG Oral TabletSCD5b443b30-5682-4cf3-9ed0-716efddbc86513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1678-169238167801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1678-1) 2020-07-110000-00-00NoNoCurrent