FDA.reportPublic FDA data

Fluoxetine hydrochloride

Product NDC
0832-6032
11-digit product format
008326032
Labeler code
0832
Product ID
0832-6032_178bf3b7-fdee-454e-9446-822a1077d985
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine hydrochloride
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA216953
Marketing category
ANDA
Marketing start
2022-11-15
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 hydrochloride
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
0832-6032-12Fluoxetine hydrochloride120 mL in 1 BOTTLEFOR SOLUTION1205
0832-6032-12Fluoxetine hydrochloride1 in 1 CARTONFOR SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-6032-12ML - Milliliter0832-6032e7589436-5be8-4e09-8ede-ce02953060f012023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-6032FLUOXETINE HYDROCHLORIDE FOR SOLUTION [UPSHER-SMITH LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20231011_be2e4325-feb9-4957-99c0-0a741a2d71a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310386FLUoxetine 20 MG in 5 mL Oral SolutionPSNbe2e4325-feb9-4957-99c0-0a741a2d71a05
310386fluoxetine 4 MG/ML Oral SolutionSCDbe2e4325-feb9-4957-99c0-0a741a2d71a05
310386fluoxetine 20 MG per 5 ML Oral SolutionSYbe2e4325-feb9-4957-99c0-0a741a2d71a05
310386fluoxetine 4 MG/ML (as fluoxetine HCl) Oral SolutionSYbe2e4325-feb9-4957-99c0-0a741a2d71a05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-6032-12008326032121 BOTTLE in 1 CARTON (0832-6032-12) / 120 mL in 1 BOTTLE1 bottle2022-11-300000-00-00NoNoCurrent