FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-6065
11-digit product format
500906065
Labeler code
50090
Product ID
50090-6065_60f6e474-597b-4231-b421-e4ef1c193f47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-6065-02024-08-11C16284748780-11030e365-3137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
50090-6065-22024-08-11C16284748780-11030e365-3137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
50090-6065-02024-01-30C16284748780-11030e365-3137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
50090-6065-22024-01-30C16284748780-11030e365-3137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6065-0Fluoxetine30 in 1 BOTTLECAPSULE303
50090-6065-2Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6065-0EA - Each50090-60657e26ba3f-26f9-4d50-b924-15797d68fe1d12022-10-06
50090-6065-2EA - Each50090-6065e5ae1d08-21bc-4c2e-9946-911fa6db5dc712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6065FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20240813_1226a67f-ec09-42f6-9d1b-9ddd862ea0a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN1226a67f-ec09-42f6-9d1b-9ddd862ea0a03
310384fluoxetine 10 MG Oral CapsuleSCD1226a67f-ec09-42f6-9d1b-9ddd862ea0a03
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY1226a67f-ec09-42f6-9d1b-9ddd862ea0a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6065-05009060650030 CAPSULE in 1 BOTTLE (50090-6065-0) 30 capsule2022-09-090000-00-00NoNoCurrent
50090-6065-25009060650290 CAPSULE in 1 BOTTLE (50090-6065-2) 90 capsule2022-09-090000-00-00NoNoCurrent