FDA.reportPublic FDA data

Fluoxetine

Product NDC
71335-0827
11-digit product format
713350827
Labeler code
71335
Product ID
71335-0827_b9d5a8f5-39f1-425d-93fa-8adf95867fdb
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
40 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 HYDROCHLORIDE40 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
71335-0827-1Fluoxetine30 in 1 BOTTLECAPSULE303
71335-0827-2Fluoxetine60 in 1 BOTTLECAPSULE603
71335-0827-3Fluoxetine100 in 1 BOTTLECAPSULE1003
71335-0827-4Fluoxetine90 in 1 BOTTLECAPSULE903
71335-0827-5Fluoxetine28 in 1 BOTTLECAPSULE283
71335-0827-6Fluoxetine180 in 1 BOTTLECAPSULE1803
71335-0827-7Fluoxetine120 in 1 BOTTLECAPSULE1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0827FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 7 package rows20190322_02283de9-6087-45f7-a9ce-3b082ce860de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN02283de9-6087-45f7-a9ce-3b082ce860de3
310385FLUoxetine 20 MG Oral CapsulePSN02283de9-6087-45f7-a9ce-3b082ce860de3
313989FLUoxetine 40 MG Oral CapsulePSN02283de9-6087-45f7-a9ce-3b082ce860de3
310384fluoxetine 10 MG Oral CapsuleSCD02283de9-6087-45f7-a9ce-3b082ce860de3
310385fluoxetine 20 MG Oral CapsuleSCD02283de9-6087-45f7-a9ce-3b082ce860de3
313989fluoxetine 40 MG Oral CapsuleSCD02283de9-6087-45f7-a9ce-3b082ce860de3
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY02283de9-6087-45f7-a9ce-3b082ce860de3
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY02283de9-6087-45f7-a9ce-3b082ce860de3
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY02283de9-6087-45f7-a9ce-3b082ce860de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0827-17133508270130 CAPSULE in 1 BOTTLE (71335-0827-1) 30 capsule2016-06-290000-00-00NoNoCurrent
71335-0827-27133508270260 CAPSULE in 1 BOTTLE (71335-0827-2) 60 capsule2016-06-290000-00-00NoNoCurrent
71335-0827-371335082703100 CAPSULE in 1 BOTTLE (71335-0827-3) 100 capsule2016-06-290000-00-00NoNoCurrent
71335-0827-47133508270490 CAPSULE in 1 BOTTLE (71335-0827-4) 90 capsule2016-06-290000-00-00NoNoCurrent
71335-0827-57133508270528 CAPSULE in 1 BOTTLE (71335-0827-5) 28 capsule2016-06-290000-00-00NoNoCurrent
71335-0827-671335082706180 CAPSULE in 1 BOTTLE (71335-0827-6) 180 capsule2016-06-290000-00-00NoNoCurrent
71335-0827-771335082707120 CAPSULE in 1 BOTTLE (71335-0827-7) 120 capsule2016-06-290000-00-00NoNoCurrent