FDA.reportPublic FDA data

FLUOXETINE

Product NDC
64380-903
11-digit product format
643800903
Labeler code
64380
Product ID
64380-903_35d9874e-1471-484c-b625-29e70a190e10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluoxetine
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA212684
Marketing category
ANDA
Marketing start
2024-08-12
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
Rxcui248642, 313990

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
64380-903-04FLUOXETINE30 in 1 BOTTLETABLET306
64380-903-06FLUOXETINE100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-903-06EA - Each64380-903af9a464b-5771-41fc-830d-bb12560844f712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-903FLUOXETINE TABLET [STRIDES PHARMA SCIENCE LIMITED]5Current NDC, 2 package rows20240812_ca749349-d0e1-4b7c-b4c0-e392e72cf0f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSN651e8c32-4519-4619-854f-4be03c6240b6100
248642fluoxetine 20 MG Oral TabletSCD651e8c32-4519-4619-854f-4be03c6240b6100
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSY651e8c32-4519-4619-854f-4be03c6240b6100
248642FLUoxetine 20 MG Oral TabletPSNca749349-d0e1-4b7c-b4c0-e392e72cf0f66
313990FLUoxetine HCl 10 MG Oral TabletPSNca749349-d0e1-4b7c-b4c0-e392e72cf0f66
313990fluoxetine 10 MG Oral TabletSCDca749349-d0e1-4b7c-b4c0-e392e72cf0f66
248642fluoxetine 20 MG Oral TabletSCDca749349-d0e1-4b7c-b4c0-e392e72cf0f66
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSYca749349-d0e1-4b7c-b4c0-e392e72cf0f66
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSYca749349-d0e1-4b7c-b4c0-e392e72cf0f66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-903-046438009030430 TABLET in 1 BOTTLE (64380-903-04) 30 tablet2024-08-12NoNoHistorical
64380-903-0664380090306100 TABLET in 1 BOTTLE (64380-903-06) 100 tablet2024-08-12NoNoHistorical