FDA.reportPublic FDA data

Fluoxetine

Product NDC
65862-306
11-digit product format
658620306
Labeler code
65862
Product ID
65862-306_75e37c2c-4f1b-4660-ae32-0ce8106b12ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079209
Marketing category
ANDA
Marketing start
2009-03-19
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310386

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-306-12Fluoxetine120 mL in 1 BOTTLE, GLASSSOLUTION12024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-306-12ML - Milliliter65862-3069c3ba0ad-abaf-4eae-bbbb-3283e07d09d712020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE SOLUTION [AUROBINDO PHARMA LIMITED]12
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE SOLUTION [AUROBINDO PHARMA LIMITED]12
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLUOXETINE SOLUTION [AUROBINDO PHARMA LIMITED]12
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMFLUOXETINE SOLUTION [AUROBINDO PHARMA LIMITED]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLUOXETINE SOLUTION [AUROBINDO PHARMA LIMITED]12
SUCROSEINACTIVE INGREDIENTC151H8M554FLUOXETINE SOLUTION [AUROBINDO PHARMA LIMITED]12
WATERINACTIVE INGREDIENT059QF0KO0RFLUOXETINE SOLUTION [AUROBINDO PHARMA LIMITED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-306FLUOXETINE SOLUTION [AUROBINDO PHARMA LIMITED]24Current NDC, Legacy NDC, 1 package rows20240124_3195db14-0cae-4b49-9fba-49b869fe92a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310386FLUoxetine 20 MG in 5 mL Oral SolutionPSN3195db14-0cae-4b49-9fba-49b869fe92a824
310386fluoxetine 4 MG/ML Oral SolutionSCD3195db14-0cae-4b49-9fba-49b869fe92a824
310386fluoxetine 20 MG per 5 ML Oral SolutionSY3195db14-0cae-4b49-9fba-49b869fe92a824
310386fluoxetine 4 MG/ML (as fluoxetine HCl) Oral SolutionSY3195db14-0cae-4b49-9fba-49b869fe92a824
310386FLUoxetine 20 MG in 5 mL Oral SolutionPSN3276a2a4-61c7-4de6-b519-3aa8b62da88f3
310386fluoxetine 4 MG/ML Oral SolutionSCD3276a2a4-61c7-4de6-b519-3aa8b62da88f3
310386fluoxetine 20 MG per 5 ML Oral SolutionSY3276a2a4-61c7-4de6-b519-3aa8b62da88f3
310386fluoxetine 4 MG/ML (as fluoxetine HCl) Oral SolutionSY3276a2a4-61c7-4de6-b519-3aa8b62da88f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-306-1265862030612120 mL in 1 BOTTLE, GLASS (65862-306-12) 120 ml2009-03-190000-00-00NoNoCurrent