FDA.reportPublic FDA data

Fluoxetine

Product NDC
46708-272
11-digit product format
467080272
Labeler code
46708
Product ID
46708-272_168a74a5-392a-4677-8188-2cc73f28437d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA090223
Marketing category
ANDA
Marketing start
2009-07-01
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
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 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
46708-272-30Fluoxetine30 in 1 BOTTLECAPSULE306
46708-272-31Fluoxetine100 in 1 BOTTLECAPSULE1006
46708-272-71Fluoxetine500 in 1 BOTTLECAPSULE5006
46708-272-91Fluoxetine1000 in 1 BOTTLECAPSULE10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-272FLUOXETINE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 4 package rows20230129_6b9c2d73-866b-44c4-8718-e7e4a9a0fb55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN6b9c2d73-866b-44c4-8718-e7e4a9a0fb556
310385FLUoxetine 20 MG Oral CapsulePSN6b9c2d73-866b-44c4-8718-e7e4a9a0fb556
313989FLUoxetine 40 MG Oral CapsulePSN6b9c2d73-866b-44c4-8718-e7e4a9a0fb556
310384fluoxetine 10 MG Oral CapsuleSCD6b9c2d73-866b-44c4-8718-e7e4a9a0fb556
310385fluoxetine 20 MG Oral CapsuleSCD6b9c2d73-866b-44c4-8718-e7e4a9a0fb556
313989fluoxetine 40 MG Oral CapsuleSCD6b9c2d73-866b-44c4-8718-e7e4a9a0fb556
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY6b9c2d73-866b-44c4-8718-e7e4a9a0fb556
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY6b9c2d73-866b-44c4-8718-e7e4a9a0fb556
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY6b9c2d73-866b-44c4-8718-e7e4a9a0fb556

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-272-304670802723030 CAPSULE in 1 BOTTLE (46708-272-30) 30 capsule2009-07-010000-00-00NoNoCurrent
46708-272-3146708027231100 CAPSULE in 1 BOTTLE (46708-272-31) 100 capsule2009-07-010000-00-00NoNoCurrent
46708-272-7146708027271500 CAPSULE in 1 BOTTLE (46708-272-71) 500 capsule2009-07-010000-00-00NoNoCurrent
46708-272-91467080272911000 CAPSULE in 1 BOTTLE (46708-272-91) 1000 capsule2009-07-010000-00-00NoNoCurrent