FDA.reportPublic FDA data

Fluoxetine

Product NDC
63629-1610
11-digit product format
636291610
Labeler code
63629
Product ID
63629-1610_badb7357-a634-40dc-97d6-e18aeaa3c1b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2027-12-31

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
63629-1610-12020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-22020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-32020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-42020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-52020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-62020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-72020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-82020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-92020-10-13C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-12020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-22020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-32020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-42020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-52020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-62020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-72020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-82020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-92020-01-31C16284748780-19d75b9d0-9bfb-f424-e053-dadaa90a57ceThese 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
63629-1610-1Fluoxetine30 in 1 BOTTLECAPSULE3023
63629-1610-2Fluoxetine100 in 1 BOTTLECAPSULE10023
63629-1610-3Fluoxetine60 in 1 BOTTLECAPSULE6023
63629-1610-4Fluoxetine15 in 1 BOTTLECAPSULE1523
63629-1610-5Fluoxetine56 in 1 BOTTLECAPSULE5623
63629-1610-6Fluoxetine28 in 1 BOTTLECAPSULE2823
63629-1610-7Fluoxetine90 in 1 BOTTLECAPSULE9023
63629-1610-8Fluoxetine120 in 1 BOTTLECAPSULE12023
63629-1610-9Fluoxetine45 in 1 BOTTLECAPSULE4523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1610-1EA - Each63629-161033267f2e-fffb-48c7-8843-d6c9d133600212012-07-24
63629-1610-2EA - Each63629-1610392dae57-45b1-4f8d-951a-f4e1b81a8d3d12012-07-24
63629-1610-3EA - Each63629-1610ce1326ff-e295-4a90-b4ae-bb0449715dc512012-07-24
63629-1610-4EA - Each63629-16106908f81c-a398-47fc-b976-637d710c73da12012-07-24
63629-1610-5EA - Each63629-1610b31116ae-7f9a-4240-9389-530aea63488412013-02-13
63629-1610-6EA - Each63629-16100d92b420-99ae-4206-9b54-23a4856b48fb12013-02-13
63629-1610-7EA - Each63629-16109be964dc-1039-4388-8a3e-20e6266e393012013-02-13
63629-1610-8EA - Each63629-1610e55084e8-fd75-4721-9e86-93e7477a1f5b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1610FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]22Current NDC, Legacy NDC, 9 package rows20240515_bb06af33-8ff7-0b02-0029-d628f62e1382.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNbb06af33-8ff7-0b02-0029-d628f62e138223
310385fluoxetine 20 MG Oral CapsuleSCDbb06af33-8ff7-0b02-0029-d628f62e138223
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYbb06af33-8ff7-0b02-0029-d628f62e138223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1610-16362916100130 CAPSULE in 1 BOTTLE (63629-1610-1) 30 capsule2022-09-020000-00-00NoNoCurrent
63629-1610-263629161002100 CAPSULE in 1 BOTTLE (63629-1610-2) 100 capsule2022-09-020000-00-00NoNoCurrent
63629-1610-36362916100360 CAPSULE in 1 BOTTLE (63629-1610-3) 60 capsule2022-09-020000-00-00NoNoCurrent
63629-1610-46362916100415 CAPSULE in 1 BOTTLE (63629-1610-4) 15 capsule2022-09-020000-00-00NoNoCurrent
63629-1610-56362916100556 CAPSULE in 1 BOTTLE (63629-1610-5) 56 capsule2010-03-040000-00-00NoNoCurrent
63629-1610-66362916100628 CAPSULE in 1 BOTTLE (63629-1610-6) 28 capsule2010-03-050000-00-00NoNoCurrent
63629-1610-76362916100790 CAPSULE in 1 BOTTLE (63629-1610-7) 90 capsule2010-03-170000-00-00NoNoCurrent
63629-1610-863629161008120 CAPSULE in 1 BOTTLE (63629-1610-8) 120 capsule2013-02-070000-00-00NoNoCurrent
63629-1610-96362916100945 CAPSULE in 1 BOTTLE (63629-1610-9) 45 capsule2022-09-020000-00-00NoNoCurrent