FDA.reportPublic FDA data

Fluoxetine

Product NDC
62332-022
11-digit product format
623320022
Labeler code
62332
Product ID
62332-022_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
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
62332-022-30Fluoxetine30 in 1 BOTTLECAPSULE3014
62332-022-31Fluoxetine100 in 1 BOTTLECAPSULE10014
62332-022-91Fluoxetine1000 in 1 BOTTLECAPSULE100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-022-31EA - Each62332-0221e1b3b4c-c77d-43dc-89fe-6ee5cfd1590512016-03-04
62332-022-91EA - Each62332-022d6e667c2-9ff2-444b-989a-b42547c5d88d12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-022FLUOXETINE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 3 package rows20250323_9de65da4-73f8-4c88-8198-c92e63224ddb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-022-306233200223030 CAPSULE in 1 BOTTLE (62332-022-30) 30 capsule2016-01-290000-00-00NoNoCurrent
62332-022-3162332002231100 CAPSULE in 1 BOTTLE (62332-022-31) 100 capsule2016-01-290000-00-00NoNoCurrent
62332-022-7162332002271500 CAPSULE in 1 BOTTLE (62332-022-71) 500 capsule2016-01-290000-00-00NoNoCurrent
62332-022-91623320022911000 CAPSULE in 1 BOTTLE (62332-022-91) 1000 capsule2016-01-290000-00-00NoNoCurrent