Fluphenazine Hydrochloride

Product NDC
43598-037
11-digit product format
435980037
Labeler code
43598
Product ID
43598-037_95c5a977-cf1e-488a-8eff-c5fabc4b73c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy�s Laboratories Inc.
Application
ANDA214534
Marketing category
ANDA
Marketing start
2021-02-15
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
43598-037-01Fluphenazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-037-01EA - Each43598-03784656129-beab-4579-b549-0ade87fcc38912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-037FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY’S LABORATORIES INC.]4Current NDC, Legacy NDC, 1 package rows20241123_98aeddfd-4f24-4d1a-820d-d0abc1733794.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNc2c6d6a1-b4b9-506d-e053-2995a90aac236
859841fluPHENAZine HCl 10 MG Oral TabletPSNc2c6d6a1-b4b9-506d-e053-2995a90aac236
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNc2c6d6a1-b4b9-506d-e053-2995a90aac236
860918fluPHENAZine HCl 5 MG Oral TabletPSNc2c6d6a1-b4b9-506d-e053-2995a90aac236
865117fluphenazine hydrochloride 1 MG Oral TabletSCDc2c6d6a1-b4b9-506d-e053-2995a90aac236
859841fluphenazine hydrochloride 10 MG Oral TabletSCDc2c6d6a1-b4b9-506d-e053-2995a90aac236
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDc2c6d6a1-b4b9-506d-e053-2995a90aac236
860918fluphenazine hydrochloride 5 MG Oral TabletSCDc2c6d6a1-b4b9-506d-e053-2995a90aac236
865117fluPHENAZine HCl 1 MG Oral TabletPSN98aeddfd-4f24-4d1a-820d-d0abc17337944
859841fluPHENAZine HCl 10 MG Oral TabletPSN98aeddfd-4f24-4d1a-820d-d0abc17337944
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN98aeddfd-4f24-4d1a-820d-d0abc17337944
860918fluPHENAZine HCl 5 MG Oral TabletPSN98aeddfd-4f24-4d1a-820d-d0abc17337944
865117fluphenazine hydrochloride 1 MG Oral TabletSCD98aeddfd-4f24-4d1a-820d-d0abc17337944
859841fluphenazine hydrochloride 10 MG Oral TabletSCD98aeddfd-4f24-4d1a-820d-d0abc17337944
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD98aeddfd-4f24-4d1a-820d-d0abc17337944
860918fluphenazine hydrochloride 5 MG Oral TabletSCD98aeddfd-4f24-4d1a-820d-d0abc17337944
859841fluPHENAZine HCl 10 MG Oral TabletPSNdbfd138a-e107-3f78-e053-2995a90a6d8c3
859841fluPHENAZine HCl 10 MG Oral TabletPSNb6eadd59-a7d0-400e-ba1d-795b9243f77d3
860918fluPHENAZine HCl 5 MG Oral TabletPSNb6eadd59-a7d0-400e-ba1d-795b9243f77d3
859841fluphenazine hydrochloride 10 MG Oral TabletSCDb6eadd59-a7d0-400e-ba1d-795b9243f77d3
859841fluphenazine hydrochloride 10 MG Oral TabletSCDdbfd138a-e107-3f78-e053-2995a90a6d8c3
860918fluphenazine hydrochloride 5 MG Oral TabletSCDb6eadd59-a7d0-400e-ba1d-795b9243f77d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-037-0143598003701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43598-037-01) 2021-02-150000-00-00NoNoCurrent