FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-6574
11-digit product format
500906574
Labeler code
50090
Product ID
50090-6574_d58637fe-31d4-41e1-a52c-6c5075b461da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204597
Marketing category
ANDA
Marketing start
2019-09-25
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
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
50090-6574-0Fluoxetine30 in 1 BOTTLECAPSULE301
50090-6574-1Fluoxetine60 in 1 BOTTLECAPSULE601
50090-6574-3Fluoxetine90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6574-0EA - Each50090-6574f0e1fad3-aada-4069-aa6f-3fedc5e773b012023-09-05
50090-6574-1EA - Each50090-6574dfa74257-79a8-4920-9266-628dab05d25e12023-09-05
50090-6574-3EA - Each50090-65748af9d799-abf4-4d37-9df5-cae0b613e3c112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6574FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230807_a5d49dee-a7de-44d8-80b5-1aeb89e76938.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNa5d49dee-a7de-44d8-80b5-1aeb89e769381
310385fluoxetine 20 MG Oral CapsuleSCDa5d49dee-a7de-44d8-80b5-1aeb89e769381
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa5d49dee-a7de-44d8-80b5-1aeb89e769381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6574-05009065740030 CAPSULE in 1 BOTTLE (50090-6574-0) 30 capsule2023-08-02NoNoHistorical
50090-6574-15009065740160 CAPSULE in 1 BOTTLE (50090-6574-1) 60 capsule2023-08-02NoNoHistorical
50090-6574-35009065740390 CAPSULE in 1 BOTTLE (50090-6574-3) 90 capsule2023-08-02NoNoHistorical