FDA.reportPublic FDA data

Fluoxetine hydrochloride

Product NDC
43598-632
11-digit product format
435980632
Labeler code
43598
Product ID
43598-632_716e99cb-d17e-d5ca-61aa-3298ab7fee96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA211721
Marketing category
ANDA
Marketing start
2019-01-28
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui1190110

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9Product name620250331
e5b459e3-ddce-4802-aab4-2c901d71ae85Product name520250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464Product name320240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-632-01Fluoxetine hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
43598-632-30Fluoxetine hydrochloride30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-632-30EA - Each43598-6321f8760ce-964e-43ae-91b1-c753ac3f8a5c12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-632FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.]5Current NDC, Legacy NDC, 2 package rows20240523_80e52273-9741-6aef-eb24-8a93ead85ba7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190110FLUoxetine HCl 60 MG Oral TabletPSN80e52273-9741-6aef-eb24-8a93ead85ba75
1190110fluoxetine 60 MG Oral TabletSCD80e52273-9741-6aef-eb24-8a93ead85ba75
1190110fluoxetine (as fluoxetine HCl) 60 MG Oral TabletSY80e52273-9741-6aef-eb24-8a93ead85ba75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-632-0143598063201100 TABLET, FILM COATED in 1 BOTTLE (43598-632-01) 2019-01-280000-00-00NoNoCurrent
43598-632-304359806323030 TABLET, FILM COATED in 1 BOTTLE (43598-632-30) 2019-01-280000-00-00NoNoCurrent