Fluoxetine

Product NDC
63187-233
11-digit product format
631870233
Labeler code
63187
Product ID
63187-233_d8af1a25-3072-4c46-a287-61f19bb7b5c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384

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
63187-233-30Fluoxetine30 in 1 BOTTLECAPSULE306
63187-233-90Fluoxetine90 in 1 BOTTLECAPSULE906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [PROFICIENT RX LP]1
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [PROFICIENT RX LP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUOXETINE CAPSULE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE CAPSULE [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE CAPSULE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-233FLUOXETINE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20241024_1a2a5194-b793-4c62-a177-040dad38526b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN1a2a5194-b793-4c62-a177-040dad38526b6
310384fluoxetine 10 MG Oral CapsuleSCD1a2a5194-b793-4c62-a177-040dad38526b6
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY1a2a5194-b793-4c62-a177-040dad38526b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-233-306318702333030 CAPSULE in 1 BOTTLE (63187-233-30)30 capsule2026-05-220Current
63187-233-906318702339090 CAPSULE in 1 BOTTLE (63187-233-90) 90 capsule2002-01-290000-00-00NoNoCurrent