FDA.reportPublic FDA data

Fluoxetine

Product NDC
68788-7909
11-digit product format
687887909
Labeler code
68788
Product ID
68788-7909_df0063a3-d229-4ca6-8e82-dacc3255029a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2021-05-18
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7909-1Fluoxetine100 in 1 BOTTLECAPSULE1007
68788-7909-3Fluoxetine30 in 1 BOTTLECAPSULE307
68788-7909-6Fluoxetine60 in 1 BOTTLECAPSULE607
68788-7909-9Fluoxetine90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7909FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20250516_e83e2220-d32a-472c-bd9f-b87d0cf8858f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNe83e2220-d32a-472c-bd9f-b87d0cf8858f7
310385fluoxetine 20 MG Oral CapsuleSCDe83e2220-d32a-472c-bd9f-b87d0cf8858f7
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYe83e2220-d32a-472c-bd9f-b87d0cf8858f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7909-168788790901100 CAPSULE in 1 BOTTLE (68788-7909-1) 100 capsule2021-05-180000-00-00NoNoCurrent
68788-7909-36878879090330 CAPSULE in 1 BOTTLE (68788-7909-3) 30 capsule2021-05-180000-00-00NoNoCurrent
68788-7909-66878879090660 CAPSULE in 1 BOTTLE (68788-7909-6) 60 capsule2021-05-180000-00-00NoNoCurrent
68788-7909-96878879090990 CAPSULE in 1 BOTTLE (68788-7909-9) 90 capsule2021-05-180000-00-00NoNoCurrent