FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
71205-839
11-digit product format
712050839
Labeler code
71205
Product ID
71205-839_bc22941e-d2e7-4165-91ea-7239c8b9882d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA215848
Marketing category
ANDA
Marketing start
2022-08-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
817a13b7-685c-6d80-08bc-347c9a7530c4Product name320171211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
adfcae9b-bddd-ca49-dfd9-a2e8267a7d37Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-839-00Fluphenazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
71205-839-11Fluphenazine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001
71205-839-30Fluphenazine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
71205-839-55Fluphenazine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
71205-839-60Fluphenazine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
71205-839-64Fluphenazine Hydrochloride240 in 1 BOTTLE, PLASTICTABLET, FILM COATED2401
71205-839-72Fluphenazine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201
71205-839-78Fluphenazine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801
71205-839-90Fluphenazine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-839-00EA - Each71205-839d481cc86-8edc-4cd0-9366-d5559a1ba4af12023-04-07
71205-839-11EA - Each71205-83907d8af2e-be4e-4d17-807c-2bae1e3184a512023-04-07
71205-839-30EA - Each71205-83917790aa5-8260-4d98-8df7-faae99fc752012023-04-07
71205-839-55EA - Each71205-83972c82fdc-a4e2-40c1-98e1-9022ac1334f612023-04-07
71205-839-60EA - Each71205-839c09bcae8-692c-47d2-b4a3-2151891e340812023-04-07
71205-839-64EA - Each71205-839a7768ad5-7e12-4dae-8842-ff9011015a1a12023-04-07
71205-839-72EA - Each71205-8394b0cffd6-2c43-4a3b-9d80-a10b21dd440212023-04-07
71205-839-78EA - Each71205-8393d376299-18bb-4b3c-869f-56bcbc2e4f9c12023-04-07
71205-839-90EA - Each71205-8395aea7143-a917-4aa8-a1b0-0d8bbfb37b7612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-839FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 9 package rows20230225_bc22941e-d2e7-4165-91ea-7239c8b9882d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNbc22941e-d2e7-4165-91ea-7239c8b9882d1
859841fluPHENAZine HCl 10 MG Oral TabletPSNbc22941e-d2e7-4165-91ea-7239c8b9882d1
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNbc22941e-d2e7-4165-91ea-7239c8b9882d1
860918fluPHENAZine HCl 5 MG Oral TabletPSNbc22941e-d2e7-4165-91ea-7239c8b9882d1
865117fluphenazine hydrochloride 1 MG Oral TabletSCDbc22941e-d2e7-4165-91ea-7239c8b9882d1
859841fluphenazine hydrochloride 10 MG Oral TabletSCDbc22941e-d2e7-4165-91ea-7239c8b9882d1
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDbc22941e-d2e7-4165-91ea-7239c8b9882d1
860918fluphenazine hydrochloride 5 MG Oral TabletSCDbc22941e-d2e7-4165-91ea-7239c8b9882d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-839-0071205083900100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-00) 2023-02-21NoNoCurrent
71205-839-11712050839111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-11) 2023-02-21NoNoCurrent
71205-839-307120508393030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-30) 2023-02-21NoNoCurrent
71205-839-5571205083955500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-55) 2023-02-21NoNoCurrent
71205-839-607120508396060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-60) 2023-02-21NoNoCurrent
71205-839-6471205083964240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-64) 2023-02-21NoNoCurrent
71205-839-7271205083972120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-72) 2023-02-21NoNoCurrent
71205-839-7871205083978180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-78) 2023-02-21NoNoCurrent
71205-839-907120508399090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-839-90) 2023-02-21NoNoCurrent