FDA.reportPublic FDA data

Fluoxetine

Product NDC
70518-3483
11-digit product format
705183483
Labeler code
70518
Product ID
70518-3483_4f1cb802-211a-cc54-e063-6294a90aa25a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2022-08-17
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3483-0Fluoxetine30 in 1 BLISTER PACKCAPSULE307
70518-3483-1Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3483FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 2 package rows20250509_8b8fe00e-7a2f-486b-9b72-465a494d8939.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN8b8fe00e-7a2f-486b-9b72-465a494d89397
310384fluoxetine 10 MG Oral CapsuleSCD8b8fe00e-7a2f-486b-9b72-465a494d89397
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY8b8fe00e-7a2f-486b-9b72-465a494d89397

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3483-07051834830030 CAPSULE in 1 BLISTER PACK (70518-3483-0) 30 capsule2022-08-170000-00-00NoNoCurrent
70518-3483-17051834830190 CAPSULE in 1 BOTTLE, PLASTIC (70518-3483-1) 90 capsule2022-09-200000-00-00NoNoCurrent