FDA.reportPublic FDA data

Fluoxetine

Product NDC
70518-3554
11-digit product format
705183554
Labeler code
70518
Product ID
70518-3554_4f58fac7-b244-631c-e063-6294a90a0434
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204597
Marketing category
ANDA
Marketing start
2022-10-13
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui313989

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
70518-3554-0Fluoxetine30 in 1 BLISTER PACKCAPSULE308
70518-3554-1Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3554-2Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3554FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250507_d121146e-7439-4169-a421-dab7b882b8aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSNd121146e-7439-4169-a421-dab7b882b8aa8
313989fluoxetine 40 MG Oral CapsuleSCDd121146e-7439-4169-a421-dab7b882b8aa8
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYd121146e-7439-4169-a421-dab7b882b8aa8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3554-07051835540030 CAPSULE in 1 BLISTER PACK (70518-3554-0) 30 capsule2022-10-130000-00-00NoNoCurrent
70518-3554-17051835540190 CAPSULE in 1 BOTTLE, PLASTIC (70518-3554-1) 90 capsule2023-03-01NoNoCurrent
70518-3554-27051835540230 CAPSULE in 1 BOTTLE, PLASTIC (70518-3554-2) 30 capsule2025-08-23NoNoCurrent