FDA.reportPublic FDA data

Fluoxetine

Product NDC
72603-488
11-digit product format
726030488
Labeler code
72603
Product ID
72603-488_3e1e767b-66a5-4f38-8142-84d40d447f92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078619
Marketing category
ANDA
Marketing start
2025-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE10 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
72603-488-01Fluoxetine100 in 1 BOTTLECAPSULE1001
72603-488-02Fluoxetine1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-488-01EA - Each72603-488b2dcab1c-7622-473d-93e7-709ce0fb8f1412025-08-11
72603-488-02EA - Each72603-488425e886f-44fb-44f4-9143-70716af1c12912025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN3e1e767b-66a5-4f38-8142-84d40d447f921
310385FLUoxetine 20 MG Oral CapsulePSN3e1e767b-66a5-4f38-8142-84d40d447f921
313989FLUoxetine 40 MG Oral CapsulePSN3e1e767b-66a5-4f38-8142-84d40d447f921
310384fluoxetine 10 MG Oral CapsuleSCD3e1e767b-66a5-4f38-8142-84d40d447f921
310385fluoxetine 20 MG Oral CapsuleSCD3e1e767b-66a5-4f38-8142-84d40d447f921
313989fluoxetine 40 MG Oral CapsuleSCD3e1e767b-66a5-4f38-8142-84d40d447f921
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY3e1e767b-66a5-4f38-8142-84d40d447f921
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY3e1e767b-66a5-4f38-8142-84d40d447f921
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY3e1e767b-66a5-4f38-8142-84d40d447f921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-488-0172603048801100 CAPSULE in 1 BOTTLE (72603-488-01) 100 capsule2025-09-01NoNoCurrent
72603-488-02726030488021000 CAPSULE in 1 BOTTLE (72603-488-02) 1000 capsule2025-09-01NoNoCurrent