FDA.reportPublic FDA data

Fluoxetine

Product NDC
68071-5240
11-digit product format
680715240
Labeler code
68071
Product ID
68071-5240_1d78bbe5-9dd6-c5d3-e063-6294a90ae352
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
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
Rxcui310385

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
68071-5240-32022-02-07C16284748780-1d6a99b39-6f46-a426-e053-dadaa90af4c2These 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
68071-5240-32022-01-28C16284748780-1d6a99b39-6f46-a426-e053-dadaa90af4c2These 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
68071-5240-3Fluoxetine30 in 1 BOTTLECAPSULE304
68071-5240-6Fluoxetine60 in 1 BOTTLECAPSULE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5240FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240719_a32f1a0b-a9ee-883a-e053-2a95a90a8c12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNa32f1a0b-a9ee-883a-e053-2a95a90a8c124
310385fluoxetine 20 MG Oral CapsuleSCDa32f1a0b-a9ee-883a-e053-2a95a90a8c124
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa32f1a0b-a9ee-883a-e053-2a95a90a8c124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5240-36807152400330 CAPSULE in 1 BOTTLE (68071-5240-3) 30 capsule2020-04-130000-00-00NoNoCurrent
68071-5240-66807152400660 CAPSULE in 1 BOTTLE (68071-5240-6) 60 capsule2020-04-130000-00-00NoNoCurrent