FDA.reportPublic FDA data

Fluoxetine

Product NDC
50228-114
11-digit product format
502280114
Labeler code
50228
Product ID
50228-114_46055a53-5131-73e6-e063-6394a90ac1db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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, 313989

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
50228-114-01Fluoxetine100 in 1 BOTTLECAPSULE10015
50228-114-05Fluoxetine500 in 1 BOTTLECAPSULE50015
50228-114-10Fluoxetine1000 in 1 BOTTLECAPSULE100015
50228-114-30Fluoxetine30 in 1 BOTTLECAPSULE3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-114-01EA - Each50228-11442980f82-c323-4cd6-9d2c-1c3a04709d6512019-07-02
50228-114-10EA - Each50228-1146b1b97c4-8248-48c1-9e22-9bb6caa759bb12019-05-02
50228-114-30EA - Each50228-114ecedca78-c4ec-4280-9d60-e23c5be1eb7012019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-114FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 4 package rows20240616_23899405-007b-48d9-82a9-a530b8e90784.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN3d5d03ff-0d0c-429f-b747-31ff3465d39d104
310385fluoxetine 20 MG Oral CapsuleSCD3d5d03ff-0d0c-429f-b747-31ff3465d39d104
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY3d5d03ff-0d0c-429f-b747-31ff3465d39d104
310384FLUoxetine 10 MG Oral CapsulePSN23899405-007b-48d9-82a9-a530b8e9078415
310385FLUoxetine 20 MG Oral CapsulePSN23899405-007b-48d9-82a9-a530b8e9078415
313989FLUoxetine 40 MG Oral CapsulePSN23899405-007b-48d9-82a9-a530b8e9078415
310384fluoxetine 10 MG Oral CapsuleSCD23899405-007b-48d9-82a9-a530b8e9078415
310385fluoxetine 20 MG Oral CapsuleSCD23899405-007b-48d9-82a9-a530b8e9078415
313989fluoxetine 40 MG Oral CapsuleSCD23899405-007b-48d9-82a9-a530b8e9078415
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY23899405-007b-48d9-82a9-a530b8e9078415
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY23899405-007b-48d9-82a9-a530b8e9078415
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY23899405-007b-48d9-82a9-a530b8e9078415
310385FLUoxetine 20 MG Oral CapsulePSNcdf3b608-e14c-474b-b80e-01ac5f7018668
310385FLUoxetine 20 MG Oral CapsulePSNcca9edf9-2454-4bf9-98e8-c531a8f5dc428
310385fluoxetine 20 MG Oral CapsuleSCDcca9edf9-2454-4bf9-98e8-c531a8f5dc428
310385fluoxetine 20 MG Oral CapsuleSCDcdf3b608-e14c-474b-b80e-01ac5f7018668
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYcca9edf9-2454-4bf9-98e8-c531a8f5dc428
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYcdf3b608-e14c-474b-b80e-01ac5f7018668
310385FLUoxetine 20 MG Oral CapsulePSNe83e2220-d32a-472c-bd9f-b87d0cf8858f7
310385fluoxetine 20 MG Oral CapsuleSCDe83e2220-d32a-472c-bd9f-b87d0cf8858f7
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYe83e2220-d32a-472c-bd9f-b87d0cf8858f7
310385FLUoxetine 20 MG Oral CapsulePSNaae4e339-5244-f6f9-e053-2995a90a42ce5
310385fluoxetine 20 MG Oral CapsuleSCDaae4e339-5244-f6f9-e053-2995a90a42ce5
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYaae4e339-5244-f6f9-e053-2995a90a42ce5
310385FLUoxetine 20 MG Oral CapsulePSNd26f7450-7650-43df-a63b-1fe2472882a94
310385FLUoxetine 20 MG Oral CapsulePSN77ae9e44-efb9-4199-ae16-061e13e260804
310385FLUoxetine 20 MG Oral CapsulePSNa32f1a0b-a9ee-883a-e053-2a95a90a8c124
310385FLUoxetine 20 MG Oral CapsulePSNa7bea6e9-cf90-a963-e053-2a95a90a10684
310385fluoxetine 20 MG Oral CapsuleSCD77ae9e44-efb9-4199-ae16-061e13e260804
310385fluoxetine 20 MG Oral CapsuleSCDd26f7450-7650-43df-a63b-1fe2472882a94
310385fluoxetine 20 MG Oral CapsuleSCDa32f1a0b-a9ee-883a-e053-2a95a90a8c124
310385fluoxetine 20 MG Oral CapsuleSCDa7bea6e9-cf90-a963-e053-2a95a90a10684
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa7bea6e9-cf90-a963-e053-2a95a90a10684
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYd26f7450-7650-43df-a63b-1fe2472882a94
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa32f1a0b-a9ee-883a-e053-2a95a90a8c124
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY77ae9e44-efb9-4199-ae16-061e13e260804
310385FLUoxetine 20 MG Oral CapsulePSNa9de93d4-2edc-2838-e053-2995a90a8ed63
310385fluoxetine 20 MG Oral CapsuleSCDa9de93d4-2edc-2838-e053-2995a90a8ed63
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa9de93d4-2edc-2838-e053-2995a90a8ed63
310385FLUoxetine 20 MG Oral CapsulePSN48705e4f-c3ee-af78-e063-6394a90ad0522
310385FLUoxetine 20 MG Oral CapsulePSNf917063a-226e-0978-e053-6294a90aeb4b2
310385FLUoxetine 20 MG Oral CapsulePSN0b3da881-475d-cdee-e063-6394a90aee992
310385fluoxetine 20 MG Oral CapsuleSCD48705e4f-c3ee-af78-e063-6394a90ad0522
310385fluoxetine 20 MG Oral CapsuleSCDf917063a-226e-0978-e053-6294a90aeb4b2
310385fluoxetine 20 MG Oral CapsuleSCD0b3da881-475d-cdee-e063-6394a90aee992
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYf917063a-226e-0978-e053-6294a90aeb4b2
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY48705e4f-c3ee-af78-e063-6394a90ad0522
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY0b3da881-475d-cdee-e063-6394a90aee992
310385FLUoxetine 20 MG Oral CapsulePSNa08dadff-f209-48dc-b597-6f085be136401
310385FLUoxetine 20 MG Oral CapsulePSN4915e22f-cecb-4261-8389-9bb417a20e821
310385FLUoxetine 20 MG Oral CapsulePSN1302fc08-d5fa-54b4-e063-6394a90a52751
310385fluoxetine 20 MG Oral CapsuleSCDa08dadff-f209-48dc-b597-6f085be136401
310385fluoxetine 20 MG Oral CapsuleSCD4915e22f-cecb-4261-8389-9bb417a20e821
310385fluoxetine 20 MG Oral CapsuleSCD1302fc08-d5fa-54b4-e063-6394a90a52751
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa08dadff-f209-48dc-b597-6f085be136401
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY4915e22f-cecb-4261-8389-9bb417a20e821
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY1302fc08-d5fa-54b4-e063-6394a90a52751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-114-0150228011401100 CAPSULE in 1 BOTTLE (50228-114-01) 100 capsule2015-03-160000-00-00NoNoCurrent
50228-114-0550228011405500 CAPSULE in 1 BOTTLE (50228-114-05) 500 capsule2015-03-160000-00-00NoNoCurrent
50228-114-10502280114101000 CAPSULE in 1 BOTTLE (50228-114-10) 1000 capsule2015-03-160000-00-00NoNoCurrent
50228-114-305022801143030 CAPSULE in 1 BOTTLE (50228-114-30) 30 capsule2015-03-160000-00-00NoNoCurrent