FDA.reportPublic FDA data

Fluoxetine

Product NDC
62332-243
11-digit product format
623320243
Labeler code
62332
Product ID
62332-243_80f85fbd-5e1b-424d-b017-e3caa30131bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA208698
Marketing category
ANDA
Marketing start
2017-04-07
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, 313990

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
62332-243-30Fluoxetine30 in 1 BOTTLETABLET, FILM COATED3011
62332-243-31Fluoxetine100 in 1 BOTTLETABLET, FILM COATED10011
62332-243-91Fluoxetine1000 in 1 BOTTLETABLET, FILM COATED100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-243FLUOXETINE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 3 package rows20230920_e9ee6e93-4a57-4fd1-a417-3944484dd32c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSNe9ee6e93-4a57-4fd1-a417-3944484dd32c11
313990FLUoxetine HCl 10 MG Oral TabletPSNe9ee6e93-4a57-4fd1-a417-3944484dd32c11
313990fluoxetine 10 MG Oral TabletSCDe9ee6e93-4a57-4fd1-a417-3944484dd32c11
248642fluoxetine 20 MG Oral TabletSCDe9ee6e93-4a57-4fd1-a417-3944484dd32c11
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSYe9ee6e93-4a57-4fd1-a417-3944484dd32c11
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSYe9ee6e93-4a57-4fd1-a417-3944484dd32c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-243-306233202433030 TABLET, FILM COATED in 1 BOTTLE (62332-243-30) 2017-04-070000-00-00NoNoCurrent
62332-243-3162332024331100 TABLET, FILM COATED in 1 BOTTLE (62332-243-31) 2017-04-070000-00-00NoNoCurrent
62332-243-91623320243911000 TABLET, FILM COATED in 1 BOTTLE (62332-243-91) 2017-04-070000-00-00NoNoCurrent