FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
71205-840
11-digit product format
712050840
Labeler code
71205
Product ID
71205-840_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
10 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 HYDROCHLORIDE10 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
71205-840-00Fluphenazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
71205-840-11Fluphenazine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001
71205-840-30Fluphenazine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
71205-840-55Fluphenazine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
71205-840-60Fluphenazine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
71205-840-64Fluphenazine Hydrochloride240 in 1 BOTTLE, PLASTICTABLET, FILM COATED2401
71205-840-72Fluphenazine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201
71205-840-78Fluphenazine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801
71205-840-90Fluphenazine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-840-00EA - Each71205-840de524e1c-eed6-4a1b-ae10-721b1d63053712023-04-07
71205-840-11EA - Each71205-8403c740285-741b-42f2-be71-db54bdc6386a12023-04-07
71205-840-30EA - Each71205-8400219a637-9e0b-4d97-8994-711dac92cc6612023-04-07
71205-840-55EA - Each71205-840123cd98f-c3e7-4e5e-855b-206616dd4e1412023-04-07
71205-840-60EA - Each71205-8400bd9d082-7c58-4e81-85aa-f77360ce763312023-04-07
71205-840-64EA - Each71205-840d71dc870-822b-4ee1-ac6a-de0c3c8ffa9412023-04-07
71205-840-72EA - Each71205-84009d8c8c9-f482-4569-a9b1-32be721104a212023-04-07
71205-840-78EA - Each71205-840a6b1ec86-3cc6-46e8-94fa-d7c77d8202ed12023-04-07
71205-840-90EA - Each71205-84020ef1f1a-3f51-48ff-a89b-c0063b38076412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-840FLUPHENAZINE 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
71205-840-0071205084000100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-00) 2023-02-21NoNoCurrent
71205-840-11712050840111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-11) 2023-02-21NoNoCurrent
71205-840-307120508403030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-30) 2023-02-21NoNoCurrent
71205-840-5571205084055500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-55) 2023-02-21NoNoCurrent
71205-840-607120508406060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-60) 2023-02-21NoNoCurrent
71205-840-6471205084064240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-64) 2023-02-21NoNoCurrent
71205-840-7271205084072120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-72) 2023-02-21NoNoCurrent
71205-840-7871205084078180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-78) 2023-02-21NoNoCurrent
71205-840-907120508409090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-840-90) 2023-02-21NoNoCurrent