FDA.reportPublic FDA data

Fluoxetine

Product NDC
71205-125
11-digit product format
712050125
Labeler code
71205
Product ID
71205-125_68fe7bbf-2dfb-4b9e-86f2-f1eb8e3937a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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
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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310385

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
71205-125-30Fluoxetine30 in 1 BOTTLECAPSULE303
71205-125-60Fluoxetine60 in 1 BOTTLECAPSULE603
71205-125-90Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-125-30EA - Each71205-125ab7bed5c-cee1-4d73-b606-c6a353dc86cd12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-125FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191115_0cba1992-3990-42a1-9d9a-77b593bbb02e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN0cba1992-3990-42a1-9d9a-77b593bbb02e3
310385fluoxetine 20 MG Oral CapsuleSCD0cba1992-3990-42a1-9d9a-77b593bbb02e3
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY0cba1992-3990-42a1-9d9a-77b593bbb02e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-125-307120501253030 CAPSULE in 1 BOTTLE (71205-125-30) 30 capsule2018-10-010000-00-00NoNoCurrent
71205-125-607120501256060 CAPSULE in 1 BOTTLE (71205-125-60) 60 capsule2018-10-010000-00-00NoNoCurrent
71205-125-907120501259090 CAPSULE in 1 BOTTLE (71205-125-90) 90 capsule2018-10-010000-00-00NoNoCurrent