FDA.reportPublic FDA data

FLUOXETINE

Product NDC
68788-8618
11-digit product format
687888618
Labeler code
68788
Product ID
68788-8618_ec67d3fd-5f16-4fc1-b174-90ede65171a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201336
Marketing category
ANDA
Marketing start
2024-03-28
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui313989

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
68788-8618-1FLUOXETINE100 in 1 BOTTLECAPSULE1003
68788-8618-3FLUOXETINE30 in 1 BOTTLECAPSULE303
68788-8618-6FLUOXETINE90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8618-1EA - Each68788-86186a721650-28e4-47e2-82d3-a5d3a032e45412024-06-10
68788-8618-3EA - Each68788-8618909ab67d-857a-455a-a768-9fb8bf00b34c12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8618FLUOXETINE CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20250516_54ded68c-1d2e-453d-b155-84c3102e1f0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN54ded68c-1d2e-453d-b155-84c3102e1f0e3
313989fluoxetine 40 MG Oral CapsuleSCD54ded68c-1d2e-453d-b155-84c3102e1f0e3
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY54ded68c-1d2e-453d-b155-84c3102e1f0e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8618-168788861801100 CAPSULE in 1 BOTTLE (68788-8618-1) 100 capsule2024-03-28NoNoHistorical
68788-8618-36878886180330 CAPSULE in 1 BOTTLE (68788-8618-3) 30 capsule2024-03-28NoNoHistorical
68788-8618-66878886180690 CAPSULE in 1 BOTTLE (68788-8618-6) 90 capsule2024-03-28NoNoHistorical