FDA.reportPublic FDA data

Fluoxetine

Product NDC
68071-2375
11-digit product format
680712375
Labeler code
68071
Product ID
68071-2375_29a539bb-42ee-dc73-e063-6394a90a5fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui313989

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2375-32024-12-19C16284748780-1f386c649-f9c9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOXETINE CAPSULES, safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
68071-2375-32023-01-30C16284748780-1f386c649-f9c9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOXETINE CAPSULES, safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2375-3Fluoxetine30 in 1 BOTTLECAPSULE302
68071-2375-9Fluoxetine90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2375FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20241222_be4c5102-e0aa-3b89-e053-2a95a90a5d9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSNbe4c5102-e0aa-3b89-e053-2a95a90a5d9d2
313989fluoxetine 40 MG Oral CapsuleSCDbe4c5102-e0aa-3b89-e053-2a95a90a5d9d2
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYbe4c5102-e0aa-3b89-e053-2a95a90a5d9d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2375-36807123750330 CAPSULE in 1 BOTTLE (68071-2375-3) 30 capsule2021-03-240000-00-00NoNoCurrent
68071-2375-96807123750990 CAPSULE in 1 BOTTLE (68071-2375-9) 90 capsule2024-12-19NoNoCurrent