FDA.reportPublic FDA data

Fluoxetine

Product NDC
68071-4033
11-digit product format
680714033
Labeler code
68071
Product ID
68071-4033_1d7a47ee-fcdb-167d-e063-6294a90a8323
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
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
68071-4033-12024-07-17C16284748780-1ba0f9c33-2584-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
68071-4033-22024-07-17C16284748780-1ba0f9c33-2584-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
68071-4033-32024-07-17C16284748780-1ba0f9c33-2584-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
68071-4033-52024-07-17C16284748780-1ba0f9c33-2584-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
68071-4033-62024-07-17C16284748780-1ba0f9c33-2584-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
68071-4033-82024-07-17C16284748780-1ba0f9c33-2584-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
68071-4033-92024-07-17C16284748780-1ba0f9c33-2584-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
68071-4033-12023-01-30C16284748780-1ba0f9c33-2584-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
68071-4033-22023-01-30C16284748780-1ba0f9c33-2584-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
68071-4033-32023-01-30C16284748780-1ba0f9c33-2584-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
68071-4033-52023-01-30C16284748780-1ba0f9c33-2584-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
68071-4033-62023-01-30C16284748780-1ba0f9c33-2584-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
68071-4033-82023-01-30C16284748780-1ba0f9c33-2584-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
68071-4033-92023-01-30C16284748780-1ba0f9c33-2584-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
68071-4033-12021-02-10C16284748780-1ba0f9c33-2584-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
68071-4033-22021-02-10C16284748780-1ba0f9c33-2584-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
68071-4033-32021-02-10C16284748780-1ba0f9c33-2584-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
68071-4033-52021-02-10C16284748780-1ba0f9c33-2584-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
68071-4033-62021-02-10C16284748780-1ba0f9c33-2584-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
68071-4033-82021-02-10C16284748780-1ba0f9c33-2584-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
68071-4033-92021-02-10C16284748780-1ba0f9c33-2584-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
68071-4033-12021-01-29C16284748780-1ba0f9c33-2584-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
68071-4033-22021-01-29C16284748780-1ba0f9c33-2584-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
68071-4033-32021-01-29C16284748780-1ba0f9c33-2584-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
68071-4033-52021-01-29C16284748780-1ba0f9c33-2584-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
68071-4033-62021-01-29C16284748780-1ba0f9c33-2584-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
68071-4033-82021-01-29C16284748780-1ba0f9c33-2584-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
68071-4033-92021-01-29C16284748780-1ba0f9c33-2584-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
68071-4033-1Fluoxetine15 in 1 BOTTLECAPSULE155
68071-4033-2Fluoxetine20 in 1 BOTTLECAPSULE205
68071-4033-3Fluoxetine30 in 1 BOTTLECAPSULE305
68071-4033-5Fluoxetine56 in 1 BOTTLECAPSULE565
68071-4033-6Fluoxetine60 in 1 BOTTLECAPSULE605
68071-4033-8Fluoxetine28 in 1 BOTTLECAPSULE285
68071-4033-9Fluoxetine90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4033FLUOXETINE CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 7 package rows20240719_5631bb72-798a-6efc-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN5631bb72-798a-6efc-e054-00144ff8d46c5
310385fluoxetine 20 MG Oral CapsuleSCD5631bb72-798a-6efc-e054-00144ff8d46c5
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY5631bb72-798a-6efc-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4033-16807140330115 CAPSULE in 1 BOTTLE (68071-4033-1) 15 capsule2017-08-070000-00-00NoNoCurrent
68071-4033-26807140330220 CAPSULE in 1 BOTTLE (68071-4033-2) 20 capsule2017-08-070000-00-00NoNoCurrent
68071-4033-36807140330330 CAPSULE in 1 BOTTLE (68071-4033-3) 30 capsule2017-08-070000-00-00NoNoCurrent
68071-4033-56807140330556 CAPSULE in 1 BOTTLE (68071-4033-5) 56 capsule2017-08-070000-00-00NoNoCurrent
68071-4033-66807140330660 CAPSULE in 1 BOTTLE (68071-4033-6) 60 capsule2017-08-070000-00-00NoNoCurrent
68071-4033-86807140330828 CAPSULE in 1 BOTTLE (68071-4033-8) 28 capsule2017-08-070000-00-00NoNoCurrent
68071-4033-96807140330990 CAPSULE in 1 BOTTLE (68071-4033-9) 90 capsule2017-08-070000-00-00NoNoCurrent