FDA.reportPublic FDA data

Fluoxetine

Product NDC
71205-178
11-digit product format
712050178
Labeler code
71205
Product ID
71205-178_42459f16-bf6e-409e-b69c-20011d31a64d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
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
71205-178-30Fluoxetine30 in 1 BOTTLECAPSULE305
71205-178-60Fluoxetine60 in 1 BOTTLECAPSULE605
71205-178-90Fluoxetine90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-178-30EA - Each71205-17898fd9382-0a7f-420b-be9b-780bf22e7f2812019-02-13
71205-178-90EA - Each71205-178ebfba1fb-40f6-4897-8c7f-66e0801520c312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-178FLUOXETINE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20241024_cece294b-c414-4832-a8a2-22fb66aabda9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNcece294b-c414-4832-a8a2-22fb66aabda95
310385fluoxetine 20 MG Oral CapsuleSCDcece294b-c414-4832-a8a2-22fb66aabda95
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYcece294b-c414-4832-a8a2-22fb66aabda95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-178-307120501783030 CAPSULE in 1 BOTTLE (71205-178-30) 30 capsule2002-01-290000-00-00NoNoCurrent
71205-178-607120501786060 CAPSULE in 1 BOTTLE (71205-178-60) 60 capsule2002-01-290000-00-00NoNoCurrent
71205-178-907120501789090 CAPSULE in 1 BOTTLE (71205-178-90) 90 capsule2002-01-290000-00-00NoNoCurrent