FDA.reportPublic FDA data

Fluoxetine

Product NDC
51655-100
11-digit product format
516550100
Labeler code
51655
Product ID
51655-100_46e3219e-b656-3d59-e063-6394a90aa00a
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
2014-05-20
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
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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-100-522024-07-23C16284748780-19d75b9d0-1b7c-f424-e053-dadaa90a57ceThese 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
51655-100-522020-01-31C16284748780-19d75b9d0-1b7c-f424-e053-dadaa90a57ceThese 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
51655-100-26Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE903
51655-100-52Fluoxetine30 in 1 BOTTLE, DISPENSINGCAPSULE303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS]1
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-100FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20240723_cb66a702-7670-4a73-98fb-0e63151a1ffb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNcb66a702-7670-4a73-98fb-0e63151a1ffb3
310385fluoxetine 20 MG Oral CapsuleSCDcb66a702-7670-4a73-98fb-0e63151a1ffb3
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYcb66a702-7670-4a73-98fb-0e63151a1ffb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-100-265165501002690 CAPSULE in 1 BOTTLE, PLASTIC (51655-100-26) 90 capsule2022-08-30NoNoCurrent
51655-100-525165501005230 CAPSULE in 1 BOTTLE, DISPENSING (51655-100-52) 30 capsule2014-05-20NoNoCurrent