FDA.reportPublic FDA data

Fluoxetine

Product NDC
68788-7817
11-digit product format
687887817
Labeler code
68788
Product ID
68788-7817_09cb2ed7-7b76-4534-a2e8-fd648598a13c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2020-11-06
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
68788-7817-3Fluoxetine30 in 1 BOTTLECAPSULE309
68788-7817-6Fluoxetine60 in 1 BOTTLECAPSULE609
68788-7817-9Fluoxetine90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7817-3EA - Each68788-781733ed2617-ae2e-4d8f-88ec-f7c1fb753ce312021-01-08
68788-7817-6EA - Each68788-7817fa908480-44de-43ec-924b-23d19d7b025012021-01-08
68788-7817-9EA - Each68788-7817f69cf695-ef2a-4cd6-95ea-7d87410de13512021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7817FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20240502_ef0fa849-a3a0-45d2-9258-da2d46bee089.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7817-36878878170330 CAPSULE in 1 BOTTLE (68788-7817-3) 30 capsule2020-11-060000-00-00NoNoCurrent
68788-7817-66878878170660 CAPSULE in 1 BOTTLE (68788-7817-6) 60 capsule2020-11-060000-00-00NoNoCurrent
68788-7817-96878878170990 CAPSULE in 1 BOTTLE (68788-7817-9) 90 capsule2020-11-060000-00-00NoNoCurrent