FDA.reportPublic FDA data

Fluoxetine

Product NDC
50228-113
11-digit product format
502280113
Labeler code
50228
Product ID
50228-113_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
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE10 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
50228-113-01Fluoxetine100 in 1 BOTTLECAPSULE10015
50228-113-05Fluoxetine500 in 1 BOTTLECAPSULE50015
50228-113-10Fluoxetine1000 in 1 BOTTLECAPSULE100015
50228-113-30Fluoxetine30 in 1 BOTTLECAPSULE3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-113-01EA - Each50228-113b7f3d242-feb3-4e45-a483-ecbac285ea9f12019-07-02
50228-113-05EA - Each50228-11350896ea5-4f68-4cf2-abfb-11eb6fa715b112019-07-02
50228-113-10EA - Each50228-113f2fd7cee-5800-4593-b73d-80789ffdf6cd12019-05-02
50228-113-30EA - Each50228-113d9376335-60b4-4ec9-9a93-6ed7c3eed19d12019-05-02

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
50228-113FLUOXETINE (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
310384FLUoxetine 10 MG Oral CapsulePSNe15646e0-a431-4b3d-8d6f-7a3d0dadfcc6104
310384fluoxetine 10 MG Oral CapsuleSCDe15646e0-a431-4b3d-8d6f-7a3d0dadfcc6104
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYe15646e0-a431-4b3d-8d6f-7a3d0dadfcc6104
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
310384FLUoxetine 10 MG Oral CapsulePSNef0fa849-a3a0-45d2-9258-da2d46bee0899
310384fluoxetine 10 MG Oral CapsuleSCDef0fa849-a3a0-45d2-9258-da2d46bee0899
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYef0fa849-a3a0-45d2-9258-da2d46bee0899
310384FLUoxetine 10 MG Oral CapsulePSN8b8fe00e-7a2f-486b-9b72-465a494d89397
310384fluoxetine 10 MG Oral CapsuleSCD8b8fe00e-7a2f-486b-9b72-465a494d89397
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY8b8fe00e-7a2f-486b-9b72-465a494d89397
310384FLUoxetine 10 MG Oral CapsulePSNab1eec9d-f755-81a2-e053-2a95a90acb3c5
310384fluoxetine 10 MG Oral CapsuleSCDab1eec9d-f755-81a2-e053-2a95a90acb3c5
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYab1eec9d-f755-81a2-e053-2a95a90acb3c5
310384FLUoxetine 10 MG Oral CapsulePSNa408c325-d2d5-4e88-85ce-96913eb581833
310384FLUoxetine 10 MG Oral CapsulePSNb1409772-e719-67f5-e053-2995a90ab5b63
310384fluoxetine 10 MG Oral CapsuleSCDa408c325-d2d5-4e88-85ce-96913eb581833
310384fluoxetine 10 MG Oral CapsuleSCDb1409772-e719-67f5-e053-2995a90ab5b63
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYb1409772-e719-67f5-e053-2995a90ab5b63
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYa408c325-d2d5-4e88-85ce-96913eb581833
310384FLUoxetine 10 MG Oral CapsulePSN5020d0d6-969e-b4cd-e063-6294a90af9d21
310384FLUoxetine 10 MG Oral CapsulePSN3453755b-3ed6-47a3-b4c7-c64758e7784c1
310384fluoxetine 10 MG Oral CapsuleSCD5020d0d6-969e-b4cd-e063-6294a90af9d21
310384fluoxetine 10 MG Oral CapsuleSCD3453755b-3ed6-47a3-b4c7-c64758e7784c1
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY5020d0d6-969e-b4cd-e063-6294a90af9d21
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY3453755b-3ed6-47a3-b4c7-c64758e7784c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-113-0150228011301100 CAPSULE in 1 BOTTLE (50228-113-01) 100 capsule2015-03-160000-00-00NoNoCurrent
50228-113-0550228011305500 CAPSULE in 1 BOTTLE (50228-113-05) 500 capsule2015-03-160000-00-00NoNoCurrent
50228-113-10502280113101000 CAPSULE in 1 BOTTLE (50228-113-10) 1000 capsule2015-03-160000-00-00NoNoCurrent
50228-113-305022801133030 CAPSULE in 1 BOTTLE (50228-113-30) 30 capsule2015-03-160000-00-00NoNoCurrent