FDA.reportPublic FDA data

Fluoxetine

Product NDC
68001-671
11-digit product format
680010671
Labeler code
68001
Product ID
68001-671_4ddbd2ee-0572-129c-e063-6394a90a2fbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078619
Marketing category
ANDA
Marketing start
2026-01-07
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
Rxcui310384, 310385, 313989

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
68001-671-00Fluoxetine100 in 1 BOTTLECAPSULE1002
68001-671-08Fluoxetine1000 in 1 BOTTLECAPSULE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-671-00EA - Each68001-6719fe80ea2-3f09-48e2-b44a-f5b8b48c9ccf12025-12-16
68001-671-08EA - Each68001-671b01f9e81-1d4c-4283-b175-5830135937dc12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNdaf33244-1348-4c34-b44c-9e35d5c48a3e2
310385FLUoxetine 20 MG Oral CapsulePSNdaf33244-1348-4c34-b44c-9e35d5c48a3e2
313989FLUoxetine 40 MG Oral CapsulePSNdaf33244-1348-4c34-b44c-9e35d5c48a3e2
310384fluoxetine 10 MG Oral CapsuleSCDdaf33244-1348-4c34-b44c-9e35d5c48a3e2
310385fluoxetine 20 MG Oral CapsuleSCDdaf33244-1348-4c34-b44c-9e35d5c48a3e2
313989fluoxetine 40 MG Oral CapsuleSCDdaf33244-1348-4c34-b44c-9e35d5c48a3e2
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYdaf33244-1348-4c34-b44c-9e35d5c48a3e2
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYdaf33244-1348-4c34-b44c-9e35d5c48a3e2
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYdaf33244-1348-4c34-b44c-9e35d5c48a3e2
310385FLUoxetine 20 MG Oral CapsulePSN851c4cfb-e1f0-4087-b13d-c07c25fea37d1
310385fluoxetine 20 MG Oral CapsuleSCD851c4cfb-e1f0-4087-b13d-c07c25fea37d1
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY851c4cfb-e1f0-4087-b13d-c07c25fea37d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-671-0068001067100100 CAPSULE in 1 BOTTLE (68001-671-00) 100 capsule2026-01-07NoNoHistorical
68001-671-08680010671081000 CAPSULE in 1 BOTTLE (68001-671-08) 1000 capsule2026-01-08NoNoHistorical