FDA.reportPublic FDA data

Fluoxetine

Product NDC
72241-008
11-digit product format
722410008
Labeler code
72241
Product ID
72241-008_f35d566f-6a36-4ba8-8f78-6c1d79900e9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA206993
Marketing category
ANDA
Marketing start
2021-09-08
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72241-008-05Fluoxetine100 in 1 BOTTLECAPSULE1004
72241-008-10Fluoxetine500 in 1 BOTTLECAPSULE5004
72241-008-11Fluoxetine1000 in 1 BOTTLECAPSULE10004
72241-008-22Fluoxetine30 in 1 BOTTLECAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-008FLUOXETINE CAPSULE [MODAVAR PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 4 package rows20241204_05b0781b-50e2-4311-bde0-430b96e2ef8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN05b0781b-50e2-4311-bde0-430b96e2ef8e4
310385FLUoxetine 20 MG Oral CapsulePSN05b0781b-50e2-4311-bde0-430b96e2ef8e4
313989FLUoxetine 40 MG Oral CapsulePSN05b0781b-50e2-4311-bde0-430b96e2ef8e4
310384fluoxetine 10 MG Oral CapsuleSCD05b0781b-50e2-4311-bde0-430b96e2ef8e4
310385fluoxetine 20 MG Oral CapsuleSCD05b0781b-50e2-4311-bde0-430b96e2ef8e4
313989fluoxetine 40 MG Oral CapsuleSCD05b0781b-50e2-4311-bde0-430b96e2ef8e4
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY05b0781b-50e2-4311-bde0-430b96e2ef8e4
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY05b0781b-50e2-4311-bde0-430b96e2ef8e4
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY05b0781b-50e2-4311-bde0-430b96e2ef8e4
310385FLUoxetine 20 MG Oral CapsulePSN50117d4f-0777-54d3-e063-6394a90a857c1
310385fluoxetine 20 MG Oral CapsuleSCD50117d4f-0777-54d3-e063-6394a90a857c1
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY50117d4f-0777-54d3-e063-6394a90a857c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-008-0572241000805100 CAPSULE in 1 BOTTLE (72241-008-05) 100 capsule2021-09-080000-00-00NoNoCurrent
72241-008-1072241000810500 CAPSULE in 1 BOTTLE (72241-008-10) 500 capsule2021-09-080000-00-00NoNoCurrent
72241-008-11722410008111000 CAPSULE in 1 BOTTLE (72241-008-11) 1000 capsule2021-09-080000-00-00NoNoCurrent
72241-008-227224100082230 CAPSULE in 1 BOTTLE (72241-008-22) 30 capsule2021-09-080000-00-00NoNoCurrent