FDA.reportPublic FDA data

Fluoxetine

Product NDC
17224-171
11-digit product format
172240171
Labeler code
17224
Product ID
17224-171_f709b80f-6425-790e-e053-6394a90a17fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
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
17224-171-21Fluoxetine21 in 1 BOTTLECAPSULE211
17224-171-30Fluoxetine30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-171FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [CALVIN SCOTT & CO., INC.]1Current NDC, 2 package rows20230318_3453755b-3ed6-47a3-b4c7-c64758e7784c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN3453755b-3ed6-47a3-b4c7-c64758e7784c1
310384fluoxetine 10 MG Oral CapsuleSCD3453755b-3ed6-47a3-b4c7-c64758e7784c1
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY3453755b-3ed6-47a3-b4c7-c64758e7784c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-171-211722401712121 CAPSULE in 1 BOTTLE (17224-171-21) 21 capsule2015-03-16NoNoCurrent
17224-171-301722401713030 CAPSULE in 1 BOTTLE (17224-171-30) 30 capsule2015-03-16NoNoCurrent