FDA.reportPublic FDA data

Fluoxetine

Product NDC
83008-047
11-digit product format
830080047
Labeler code
83008
Product ID
83008-047_35052332-06b5-4185-9440-f9d942e57ae9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA204597
Marketing category
ANDA
Marketing start
2023-12-11
Marketing end
2026-07-31
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310385

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
83008-047-30Fluoxetine30 in 1 BOTTLECAPSULE304
83008-047-90Fluoxetine90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83008-047FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [QUALITY CARE PRODUCTS, LLC]4Current NDC, 2 package rows20241222_77ae9e44-efb9-4199-ae16-061e13e26080.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN77ae9e44-efb9-4199-ae16-061e13e260804
310385fluoxetine 20 MG Oral CapsuleSCD77ae9e44-efb9-4199-ae16-061e13e260804
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY77ae9e44-efb9-4199-ae16-061e13e260804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83008-047-308300800473030 CAPSULE in 1 BOTTLE (83008-047-30) 30 capsule2024-01-042026-07-31NoNoHistorical
83008-047-908300800479090 CAPSULE in 1 BOTTLE (83008-047-90) 90 capsule2023-12-112026-07-31NoNoHistorical