FDA.reportPublic FDA data

Fluoxetine

Product NDC
63187-069
11-digit product format
631870069
Labeler code
63187
Product ID
63187-069_27cdbe64-490e-4b1d-85da-f4a72a883098
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
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
Rxcui310384, 310385

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
63187-069-30Fluoxetine30 in 1 BOTTLECAPSULE309
63187-069-60Fluoxetine60 in 1 BOTTLECAPSULE609
63187-069-90Fluoxetine90 in 1 BOTTLECAPSULE909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-069FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]9Current NDC, Legacy NDC, 3 package rows20220609_70e115cc-6e9b-4b96-a1a9-779ed51ad0a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN70e115cc-6e9b-4b96-a1a9-779ed51ad0a79
310385FLUoxetine 20 MG Oral CapsulePSN70e115cc-6e9b-4b96-a1a9-779ed51ad0a79
310384fluoxetine 10 MG Oral CapsuleSCD70e115cc-6e9b-4b96-a1a9-779ed51ad0a79
310385fluoxetine 20 MG Oral CapsuleSCD70e115cc-6e9b-4b96-a1a9-779ed51ad0a79
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY70e115cc-6e9b-4b96-a1a9-779ed51ad0a79
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY70e115cc-6e9b-4b96-a1a9-779ed51ad0a79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-069-306318700693030 CAPSULE in 1 BOTTLE (63187-069-30) 30 capsule2014-04-300000-00-00NoNoCurrent
63187-069-606318700696060 CAPSULE in 1 BOTTLE (63187-069-60) 60 capsule2014-04-300000-00-00NoNoCurrent
63187-069-906318700699090 CAPSULE in 1 BOTTLE (63187-069-90) 90 capsule2014-04-300000-00-00NoNoCurrent