FDA.reportPublic FDA data

Fluphenazine Hydrochloride

Product NDC
70954-276
11-digit product format
709540276
Labeler code
70954
Product ID
70954-276_b62e66ce-9c80-46f1-bb86-68f7f73c487c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA214674
Marketing category
ANDA
Marketing start
2021-03-01
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
817a13b7-685c-6d80-08bc-347c9a7530c4Product name320171211
adfcae9b-bddd-ca49-dfd9-a2e8267a7d37Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-276-10Fluphenazine Hydrochloride100 in 1 BOTTLETABLET1002
70954-276-20Fluphenazine Hydrochloride500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-276-10EA - Each70954-27680e0e25e-7e86-46c5-8cb9-97d874c3d32b12021-04-08
70954-276-20EA - Each70954-276df575046-443f-4cfe-9493-d72d80b104d912021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-276FLUPHENAZINE HYDROCHLORIDE TABLET [ANI PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20250125_6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNc69f07b1-660c-db03-e053-2995a90a54644
859841fluPHENAZine HCl 10 MG Oral TabletPSNc69f07b1-660c-db03-e053-2995a90a54644
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNc69f07b1-660c-db03-e053-2995a90a54644
860918fluPHENAZine HCl 5 MG Oral TabletPSNc69f07b1-660c-db03-e053-2995a90a54644
865117fluphenazine hydrochloride 1 MG Oral TabletSCDc69f07b1-660c-db03-e053-2995a90a54644
859841fluphenazine hydrochloride 10 MG Oral TabletSCDc69f07b1-660c-db03-e053-2995a90a54644
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDc69f07b1-660c-db03-e053-2995a90a54644
860918fluphenazine hydrochloride 5 MG Oral TabletSCDc69f07b1-660c-db03-e053-2995a90a54644
865117fluPHENAZine HCl 1 MG Oral TabletPSN6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2
859841fluPHENAZine HCl 10 MG Oral TabletPSN6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2
860918fluPHENAZine HCl 5 MG Oral TabletPSN6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2
865117fluphenazine hydrochloride 1 MG Oral TabletSCD6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2
859841fluphenazine hydrochloride 10 MG Oral TabletSCD6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2
860918fluphenazine hydrochloride 5 MG Oral TabletSCD6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-276-1070954027610100 TABLET in 1 BOTTLE (70954-276-10) 100 tablet2021-03-010000-00-00NoNoCurrent
70954-276-2070954027620500 TABLET in 1 BOTTLE (70954-276-20) 500 tablet2021-03-010000-00-00NoNoCurrent