FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
71205-838
11-digit product format
712050838
Labeler code
71205
Product ID
71205-838_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
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
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
71205-838-00Fluphenazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
71205-838-11Fluphenazine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001
71205-838-30Fluphenazine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
71205-838-55Fluphenazine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
71205-838-60Fluphenazine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
71205-838-64Fluphenazine Hydrochloride240 in 1 BOTTLE, PLASTICTABLET, FILM COATED2401
71205-838-72Fluphenazine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201
71205-838-78Fluphenazine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801
71205-838-90Fluphenazine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-838-00EA - Each71205-83879c35176-e9b7-43af-bb3c-ad1ef79c162a12023-04-07
71205-838-11EA - Each71205-838f0195984-886e-4d6a-bfe0-37d227b4fd7e12023-04-07
71205-838-30EA - Each71205-838f20e8310-7911-4e3f-b25b-ed09f9e59fef12023-04-07
71205-838-55EA - Each71205-83881a36e71-c2bd-4b40-900e-c03ed41d86ab12023-04-07
71205-838-60EA - Each71205-838d7a87276-3cdb-493f-ab19-8b7f11f852b012023-04-07
71205-838-64EA - Each71205-83889f3beea-c1a3-4064-820c-f12956ac1e1612023-04-07
71205-838-72EA - Each71205-838d2874e8a-5945-43c8-96fd-f0e77e28722012023-04-07
71205-838-78EA - Each71205-838d64b349d-80bb-4d1a-8aa5-e542bf1eb59e12023-04-07
71205-838-90EA - Each71205-83849aca0f2-9d85-4c54-afb2-b9bc48488c5d12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-838FLUPHENAZINE 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
71205-838-0071205083800100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-00) 2023-02-21NoNoCurrent
71205-838-11712050838111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-11) 2023-02-21NoNoCurrent
71205-838-307120508383030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-30) 2023-02-21NoNoCurrent
71205-838-5571205083855500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-55) 2023-02-21NoNoCurrent
71205-838-607120508386060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-60) 2023-02-21NoNoCurrent
71205-838-6471205083864240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-64) 2023-02-21NoNoCurrent
71205-838-7271205083872120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-72) 2023-02-21NoNoCurrent
71205-838-7871205083878180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-78) 2023-02-21NoNoCurrent
71205-838-907120508389090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-90) 2023-02-21NoNoCurrent