FDA.reportPublic FDA data

Fluoxetine

Product NDC
77771-113
11-digit product format
777710113
Labeler code
77771
Product ID
77771-113_3752a193-ad76-4757-8f0a-64d556fe389a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RADHA PHARMACEUTICALS, INC.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2022-10-24
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, 310385, 313989

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77771-113-01Fluoxetine100 in 1 BOTTLECAPSULE1003
77771-113-10Fluoxetine1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77771-113-01EA - Each77771-1134420e85c-a95a-4885-8594-7a728815c59612022-12-07
77771-113-10EA - Each77771-113757e9def-a36b-485e-94a2-11395e40d61112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77771-113FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [RADHA PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20240709_1a07ebe9-3661-4a48-b8af-9b228875166a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN06582152-d7d3-4e87-8c13-a4416a6ec9273
310384FLUoxetine 10 MG Oral CapsulePSN1a07ebe9-3661-4a48-b8af-9b228875166a3
310385FLUoxetine 20 MG Oral CapsulePSN06582152-d7d3-4e87-8c13-a4416a6ec9273
310385FLUoxetine 20 MG Oral CapsulePSN1a07ebe9-3661-4a48-b8af-9b228875166a3
313989FLUoxetine 40 MG Oral CapsulePSN1a07ebe9-3661-4a48-b8af-9b228875166a3
310384fluoxetine 10 MG Oral CapsuleSCD06582152-d7d3-4e87-8c13-a4416a6ec9273
310384fluoxetine 10 MG Oral CapsuleSCD1a07ebe9-3661-4a48-b8af-9b228875166a3
310385fluoxetine 20 MG Oral CapsuleSCD06582152-d7d3-4e87-8c13-a4416a6ec9273
310385fluoxetine 20 MG Oral CapsuleSCD1a07ebe9-3661-4a48-b8af-9b228875166a3
313989fluoxetine 40 MG Oral CapsuleSCD1a07ebe9-3661-4a48-b8af-9b228875166a3
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY06582152-d7d3-4e87-8c13-a4416a6ec9273
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY1a07ebe9-3661-4a48-b8af-9b228875166a3
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY06582152-d7d3-4e87-8c13-a4416a6ec9273
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY1a07ebe9-3661-4a48-b8af-9b228875166a3
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY1a07ebe9-3661-4a48-b8af-9b228875166a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77771-113-0177771011301100 CAPSULE in 1 BOTTLE (77771-113-01) 100 capsule2022-10-240000-00-00NoNoCurrent
77771-113-10777710113101000 CAPSULE in 1 BOTTLE (77771-113-10) 1000 capsule2022-10-240000-00-00NoNoCurrent