FDA.reportPublic FDA data

Fluoxetine

Product NDC
43598-566
11-digit product format
435980566
Labeler code
43598
Product ID
43598-566_5d9a91f6-93bc-2002-8876-20139830dbb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Inc.
Application
ANDA076006
Marketing category
ANDA
Marketing start
2018-05-08
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui248642

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
43598-566-01Fluoxetine100 in 1 BOTTLETABLET, FILM COATED1007
43598-566-10Fluoxetine1000 in 1 BOTTLETABLET, FILM COATED10007
43598-566-30Fluoxetine30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-566-01EA - Each43598-566cf9003ea-c3c6-4564-b684-6233a2cb673612018-07-03
43598-566-30EA - Each43598-566c7ded0e6-90fe-43b6-b7c6-0f22c9cce39112018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-566FLUOXETINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC.]7Current NDC, Legacy NDC, 3 package rows20230906_390c61e6-14dd-4391-45b8-0fb5f4652723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSN390c61e6-14dd-4391-45b8-0fb5f46527237
248642fluoxetine 20 MG Oral TabletSCD390c61e6-14dd-4391-45b8-0fb5f46527237
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSY390c61e6-14dd-4391-45b8-0fb5f46527237

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-566-0143598056601100 TABLET, FILM COATED in 1 BOTTLE (43598-566-01) 2018-05-080000-00-00NoNoCurrent
43598-566-10435980566101000 TABLET, FILM COATED in 1 BOTTLE (43598-566-10) 2018-05-080000-00-00NoNoCurrent
43598-566-304359805663030 TABLET, FILM COATED in 1 BOTTLE (43598-566-30) 2018-05-080000-00-00NoNoCurrent