FDA.reportPublic FDA data

Fluoxetine

Product NDC
71209-040
11-digit product format
712090040
Labeler code
71209
Product ID
71209-040_1922c101-5662-4952-9ac2-6470bbfd5ad3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA206993
Marketing category
ANDA
Marketing start
2022-12-15
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
71209-040-01Fluoxetine30 in 1 BOTTLECAPSULE3011
71209-040-05Fluoxetine100 in 1 BOTTLECAPSULE10011
71209-040-10Fluoxetine500 in 1 BOTTLECAPSULE50011
71209-040-11Fluoxetine1000 in 1 BOTTLECAPSULE100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-040FLUOXETINE CAPSULE [CADILA PHARMACEUTICALS LIMITED]11Current NDC, Legacy NDC, 4 package rows20240717_9651816f-58f5-4bf8-8183-6f3d84d36b5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN9651816f-58f5-4bf8-8183-6f3d84d36b5c11
310385FLUoxetine 20 MG Oral CapsulePSN9651816f-58f5-4bf8-8183-6f3d84d36b5c11
313989FLUoxetine 40 MG Oral CapsulePSN9651816f-58f5-4bf8-8183-6f3d84d36b5c11
310384fluoxetine 10 MG Oral CapsuleSCD9651816f-58f5-4bf8-8183-6f3d84d36b5c11
310385fluoxetine 20 MG Oral CapsuleSCD9651816f-58f5-4bf8-8183-6f3d84d36b5c11
313989fluoxetine 40 MG Oral CapsuleSCD9651816f-58f5-4bf8-8183-6f3d84d36b5c11
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY9651816f-58f5-4bf8-8183-6f3d84d36b5c11
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY9651816f-58f5-4bf8-8183-6f3d84d36b5c11
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY9651816f-58f5-4bf8-8183-6f3d84d36b5c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-040-017120900400130 CAPSULE in 1 BOTTLE (71209-040-01) 30 capsule2022-12-150000-00-00NoNoCurrent
71209-040-0571209004005100 CAPSULE in 1 BOTTLE (71209-040-05) 100 capsule2022-12-150000-00-00NoNoCurrent
71209-040-1071209004010500 CAPSULE in 1 BOTTLE (71209-040-10) 500 capsule2022-12-150000-00-00NoNoCurrent
71209-040-11712090040111000 CAPSULE in 1 BOTTLE (71209-040-11) 1000 capsule2022-12-150000-00-00NoNoCurrent