FDA.reportPublic FDA data

Fluoxetine

Product NDC
51655-750
11-digit product format
516550750
Labeler code
51655
Product ID
51655-750_495166d9-9066-617a-e063-6394a90a2836
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078619
Marketing category
ANDA
Marketing start
2021-07-12
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
2027-12-31
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
51655-750-26Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE903
51655-750-52Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-750FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240727_da6b9b19-2ea1-9a39-e053-2995a90ad730.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNda6b9b19-2ea1-9a39-e053-2995a90ad7303
310384fluoxetine 10 MG Oral CapsuleSCDda6b9b19-2ea1-9a39-e053-2995a90ad7303
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYda6b9b19-2ea1-9a39-e053-2995a90ad7303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-750-265165507502690 CAPSULE in 1 BOTTLE, PLASTIC (51655-750-26) 90 capsule2022-09-01NoNoHistorical
51655-750-525165507505230 CAPSULE in 1 BOTTLE, PLASTIC (51655-750-52) 30 capsule2021-07-12NoNoHistorical