FDA.reportPublic FDA data

Fluoxetine

Product NDC
68071-4606
11-digit product format
680714606
Labeler code
68071
Product ID
68071-4606_1ab615b2-0f7d-911f-e063-6294a90a1479
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
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

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
68071-4606-32024-06-12C16284748780-1ba0f9c33-1ba1-a910-e053-dadaa90a0b85These 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
68071-4606-32023-01-30C16284748780-1ba0f9c33-1ba1-a910-e053-dadaa90a0b85These 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
68071-4606-32021-02-22C16284748780-1ba0f9c33-1ba1-a910-e053-dadaa90a0b85These 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
68071-4606-32021-01-29C16284748780-1ba0f9c33-1ba1-a910-e053-dadaa90a0b85These 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
68071-4606-3Fluoxetine30 in 1 BOTTLECAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4606FLUOXETINE CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240614_78994632-74b3-951c-e053-2a91aa0ac1c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN78994632-74b3-951c-e053-2a91aa0ac1c84
310384fluoxetine 10 MG Oral CapsuleSCD78994632-74b3-951c-e053-2a91aa0ac1c84
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY78994632-74b3-951c-e053-2a91aa0ac1c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4606-36807146060330 CAPSULE in 1 BOTTLE (68071-4606-3) 30 capsule2018-10-190000-00-00NoNoCurrent