FDA.reportPublic FDA data

Fluoxetine

Product NDC
71335-1548
11-digit product format
713351548
Labeler code
71335
Product ID
71335-1548_c1d88c7e-4490-4618-9d78-93be301e14c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2026-12-31

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
71335-1548-1Fluoxetine30 in 1 BOTTLECAPSULE30104
71335-1548-2Fluoxetine90 in 1 BOTTLECAPSULE90104
71335-1548-3Fluoxetine60 in 1 BOTTLECAPSULE60104
71335-1548-4Fluoxetine120 in 1 BOTTLECAPSULE120104
71335-1548-5Fluoxetine28 in 1 BOTTLECAPSULE28104
71335-1548-6Fluoxetine15 in 1 BOTTLECAPSULE15104
71335-1548-7Fluoxetine100 in 1 BOTTLECAPSULE100104
71335-1548-8Fluoxetine180 in 1 BOTTLECAPSULE180104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1548FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 8 package rows20240824_e15646e0-a431-4b3d-8d6f-7a3d0dadfcc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNe15646e0-a431-4b3d-8d6f-7a3d0dadfcc6104
310384fluoxetine 10 MG Oral CapsuleSCDe15646e0-a431-4b3d-8d6f-7a3d0dadfcc6104
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYe15646e0-a431-4b3d-8d6f-7a3d0dadfcc6104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1548-17133515480130 CAPSULE in 1 BOTTLE (71335-1548-1) 30 capsule2020-06-290000-00-00NoNoCurrent
71335-1548-27133515480290 CAPSULE in 1 BOTTLE (71335-1548-2) 90 capsule2020-07-240000-00-00NoNoCurrent
71335-1548-37133515480360 CAPSULE in 1 BOTTLE (71335-1548-3) 60 capsule2024-07-170000-00-00NoNoCurrent
71335-1548-471335154804120 CAPSULE in 1 BOTTLE (71335-1548-4) 120 capsule2024-07-170000-00-00NoNoCurrent
71335-1548-57133515480528 CAPSULE in 1 BOTTLE (71335-1548-5) 28 capsule2024-07-170000-00-00NoNoCurrent
71335-1548-67133515480615 CAPSULE in 1 BOTTLE (71335-1548-6) 15 capsule2024-07-170000-00-00NoNoCurrent
71335-1548-771335154807100 CAPSULE in 1 BOTTLE (71335-1548-7) 100 capsule2022-01-200000-00-00NoNoCurrent
71335-1548-871335154808180 CAPSULE in 1 BOTTLE (71335-1548-8) 180 capsule2024-07-170000-00-00NoNoCurrent