FDA.reportPublic FDA data

Fluoxetine

Product NDC
13668-443
11-digit product format
136680443
Labeler code
13668
Product ID
13668-443_f8d8c930-c8f9-4186-92fa-6f7a5dabe083
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA206937
Marketing category
ANDA
Marketing start
2016-10-21
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
Rxcui2532159, 2532163

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
13668-443-01Fluoxetine100 in 1 BOTTLETABLET10013
13668-443-10Fluoxetine1000 in 1 BOTTLETABLET100013
13668-443-30Fluoxetine30 in 1 BOTTLETABLET3013
13668-443-74Fluoxetine100 in 1 CARTONTABLET10013
13668-443-91Fluoxetine28 in 1 CARTONTABLET2813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-443-01EA - Each13668-443cfbb2a5d-ed60-4b76-84f4-ffe3ecba300012016-12-07
13668-443-10EA - Each13668-4432c5d63ff-d223-402b-96b8-f8098bed7b5b12016-12-07
13668-443-30EA - Each13668-4432fd93b41-22da-48c7-986b-1166b0f64fe712016-12-07
13668-443-91EA - Each13668-4433eba998e-0abf-4981-a15a-4e69a7ff0ad012017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-443FLUOXETINE TABLET [TORRENT PHARMACEUTICALS LIMITED]13Current NDC, Legacy NDC, 5 package rows20241213_dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2532159FLUoxetine 10 MG Oral Tablet (PMDD)PSNdcebc7cf-6f95-4f7a-a22b-c7d2e0f04d7413
2532163FLUoxetine 20 MG Oral Tablet (PMDD)PSNdcebc7cf-6f95-4f7a-a22b-c7d2e0f04d7413
2532159PMDD fluoxetine 10 MG Oral TabletSCDdcebc7cf-6f95-4f7a-a22b-c7d2e0f04d7413
2532163PMDD fluoxetine 20 MG Oral TabletSCDdcebc7cf-6f95-4f7a-a22b-c7d2e0f04d7413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-443-0113668044301100 TABLET in 1 BOTTLE (13668-443-01) 100 tablet2016-10-210000-00-00NoNoCurrent
13668-443-10136680443101000 TABLET in 1 BOTTLE (13668-443-10) 1000 tablet2016-10-210000-00-00NoNoCurrent
13668-443-301366804433030 TABLET in 1 BOTTLE (13668-443-30) 30 tablet2016-10-210000-00-00NoNoCurrent
13668-443-7413668044374100 TABLET in 1 CARTON (13668-443-74) 100 tablet2016-10-210000-00-00NoNoCurrent
13668-443-911366804439128 TABLET in 1 CARTON (13668-443-91) 28 tablet2016-10-210000-00-00NoNoCurrent