FDA.reportPublic FDA data

Fluoxetine

Product NDC
63629-1609
11-digit product format
636291609
Labeler code
63629
Product ID
63629-1609_6aceb68e-92a2-4e39-b95b-569d30c70ce3
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
10 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 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
63629-1609-12020-10-13C16284748780-19d75b9d0-638e-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
63629-1609-22020-10-13C16284748780-19d75b9d0-638e-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
63629-1609-32020-10-13C16284748780-19d75b9d0-638e-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
63629-1609-42020-10-13C16284748780-19d75b9d0-638e-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
63629-1609-52020-10-13C16284748780-19d75b9d0-638e-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
63629-1609-62020-10-13C16284748780-19d75b9d0-638e-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
63629-1609-72020-10-13C16284748780-19d75b9d0-638e-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
63629-1609-12020-01-31C16284748780-19d75b9d0-638e-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
63629-1609-22020-01-31C16284748780-19d75b9d0-638e-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
63629-1609-32020-01-31C16284748780-19d75b9d0-638e-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
63629-1609-42020-01-31C16284748780-19d75b9d0-638e-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
63629-1609-52020-01-31C16284748780-19d75b9d0-638e-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
63629-1609-62020-01-31C16284748780-19d75b9d0-638e-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
63629-1609-72020-01-31C16284748780-19d75b9d0-638e-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
63629-1609-1Fluoxetine30 in 1 BOTTLECAPSULE3025
63629-1609-2Fluoxetine90 in 1 BOTTLECAPSULE9025
63629-1609-3Fluoxetine60 in 1 BOTTLECAPSULE6025
63629-1609-4Fluoxetine120 in 1 BOTTLECAPSULE12025
63629-1609-5Fluoxetine28 in 1 BOTTLECAPSULE2825
63629-1609-6Fluoxetine15 in 1 BOTTLECAPSULE1525
63629-1609-7Fluoxetine100 in 1 BOTTLECAPSULE10025
63629-1609-8Fluoxetine180 in 1 BOTTLECAPSULE18025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1609-1EA - Each63629-1609452941b5-27e4-48a0-8a66-a032ec88767a12012-07-24
63629-1609-2EA - Each63629-16096efe90a3-c8b8-4feb-8f4d-ec9f58ce039812012-07-24
63629-1609-3EA - Each63629-160926013730-41d9-42d3-ade1-9cc3b05cb82412012-07-24
63629-1609-4EA - Each63629-1609cdbf1bea-69e8-47ff-aae5-95e96791c2f612012-07-24

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
63629-1609FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]24Current NDC, Legacy NDC, 8 package rows20240515_3ccada47-7eb9-285d-5059-06afb4466114.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN3ccada47-7eb9-285d-5059-06afb446611425
310384fluoxetine 10 MG Oral CapsuleSCD3ccada47-7eb9-285d-5059-06afb446611425
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY3ccada47-7eb9-285d-5059-06afb446611425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1609-16362916090130 CAPSULE in 1 BOTTLE (63629-1609-1) 30 capsule2022-09-020000-00-00NoNoCurrent
63629-1609-26362916090290 CAPSULE in 1 BOTTLE (63629-1609-2) 90 capsule2022-09-020000-00-00NoNoCurrent
63629-1609-36362916090360 CAPSULE in 1 BOTTLE (63629-1609-3) 60 capsule2009-04-230000-00-00NoNoCurrent
63629-1609-463629160904120 CAPSULE in 1 BOTTLE (63629-1609-4) 120 capsule2009-07-310000-00-00NoNoCurrent
63629-1609-56362916090528 CAPSULE in 1 BOTTLE (63629-1609-5) 28 capsule2022-09-020000-00-00NoNoCurrent
63629-1609-66362916090615 CAPSULE in 1 BOTTLE (63629-1609-6) 15 capsule2022-09-020000-00-00NoNoCurrent
63629-1609-763629160907100 CAPSULE in 1 BOTTLE (63629-1609-7) 100 capsule2022-09-020000-00-00NoNoCurrent
63629-1609-863629160908180 CAPSULE in 1 BOTTLE (63629-1609-8) 180 capsule2022-09-020000-00-00NoNoCurrent