Fluoxetine

Product NDC
62332-024
11-digit product format
623320024
Labeler code
62332
Product ID
62332-024_88b2df81-f3ba-4455-8dc5-8fd2eb4929f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA090223
Marketing category
ANDA
Marketing start
2016-01-29
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
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 HYDROCHLORIDE40 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
62332-024-30Fluoxetine30 in 1 BOTTLECAPSULE3014
62332-024-31Fluoxetine100 in 1 BOTTLECAPSULE10014
62332-024-71Fluoxetine500 in 1 BOTTLECAPSULE50014
62332-024-91Fluoxetine1000 in 1 BOTTLECAPSULE100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-024-30EA - Each62332-024f69db71d-258b-497f-939d-fb29cbd61d4212016-11-08
62332-024-31EA - Each62332-02417938cd0-8d26-4679-a232-2a5f7751022312016-03-04
62332-024-71EA - Each62332-0249b946b26-34c5-4083-9778-b3ba5eae738712025-10-14
62332-024-91EA - Each62332-0244a4bfcb1-b5af-431c-ba59-e2620d072d4512016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-024FLUOXETINE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 4 package rows20250323_9de65da4-73f8-4c88-8198-c92e63224ddb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN620ecf00-5473-4420-afd1-94b5b38e730116
313989fluoxetine 40 MG Oral CapsuleSCD620ecf00-5473-4420-afd1-94b5b38e730116
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY620ecf00-5473-4420-afd1-94b5b38e730116
310384FLUoxetine 10 MG Oral CapsulePSN9de65da4-73f8-4c88-8198-c92e63224ddb14
310385FLUoxetine 20 MG Oral CapsulePSN9de65da4-73f8-4c88-8198-c92e63224ddb14
313989FLUoxetine 40 MG Oral CapsulePSN9de65da4-73f8-4c88-8198-c92e63224ddb14
310384fluoxetine 10 MG Oral CapsuleSCD9de65da4-73f8-4c88-8198-c92e63224ddb14
310385fluoxetine 20 MG Oral CapsuleSCD9de65da4-73f8-4c88-8198-c92e63224ddb14
313989fluoxetine 40 MG Oral CapsuleSCD9de65da4-73f8-4c88-8198-c92e63224ddb14
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY9de65da4-73f8-4c88-8198-c92e63224ddb14
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY9de65da4-73f8-4c88-8198-c92e63224ddb14
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY9de65da4-73f8-4c88-8198-c92e63224ddb14
313989FLUoxetine 40 MG Oral CapsulePSN5cccc071-9aa0-2995-e053-2991aa0a7f9a2
313989fluoxetine 40 MG Oral CapsuleSCD5cccc071-9aa0-2995-e053-2991aa0a7f9a2
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY5cccc071-9aa0-2995-e053-2991aa0a7f9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-024-306233200243030 CAPSULE in 1 BOTTLE (62332-024-30) 30 capsule2016-01-290000-00-00NoNoCurrent
62332-024-3162332002431100 CAPSULE in 1 BOTTLE (62332-024-31) 100 capsule2016-01-290000-00-00NoNoCurrent
62332-024-7162332002471500 CAPSULE in 1 BOTTLE (62332-024-71) 500 capsule2016-01-290000-00-00NoNoCurrent
62332-024-91623320024911000 CAPSULE in 1 BOTTLE (62332-024-91) 1000 capsule2016-01-290000-00-00NoNoCurrent