FDA.reportPublic FDA data

FLUOXETINE

Product NDC
42571-388
11-digit product format
425710388
Labeler code
42571
Product ID
42571-388_0770266d-0043-f296-e063-6294a90a1d1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA216232
Marketing category
ANDA
Marketing start
2023-01-01
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
42571-388-01FLUOXETINE100 in 1 BOTTLECAPSULE1002
42571-388-10FLUOXETINE1000 in 1 BOTTLECAPSULE10002
42571-388-30FLUOXETINE30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-388FLUOXETINE (FLUOXETINE) CAPSULE [MICRO LABS LIMITED]2Current NDC, Legacy NDC, 3 package rows20231012_77b01a37-ba10-4b67-a375-244dfcd94c00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN77b01a37-ba10-4b67-a375-244dfcd94c002
310385FLUoxetine 20 MG Oral CapsulePSN77b01a37-ba10-4b67-a375-244dfcd94c002
313989FLUoxetine 40 MG Oral CapsulePSN77b01a37-ba10-4b67-a375-244dfcd94c002
310384fluoxetine 10 MG Oral CapsuleSCD77b01a37-ba10-4b67-a375-244dfcd94c002
310385fluoxetine 20 MG Oral CapsuleSCD77b01a37-ba10-4b67-a375-244dfcd94c002
313989fluoxetine 40 MG Oral CapsuleSCD77b01a37-ba10-4b67-a375-244dfcd94c002
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY77b01a37-ba10-4b67-a375-244dfcd94c002
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY77b01a37-ba10-4b67-a375-244dfcd94c002
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY77b01a37-ba10-4b67-a375-244dfcd94c002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-388-0142571038801100 CAPSULE in 1 BOTTLE (42571-388-01) 100 capsule2023-01-010000-00-00NoNoCurrent
42571-388-10425710388101000 CAPSULE in 1 BOTTLE (42571-388-10) 1000 capsule2023-01-010000-00-00NoNoCurrent
42571-388-304257103883030 CAPSULE in 1 BOTTLE (42571-388-30) 30 capsule2023-01-010000-00-00NoNoCurrent