FDA.reportPublic FDA data

fluoxetine hydrochloride

Product NDC
63629-8989
11-digit product format
636298989
Labeler code
63629
Product ID
63629-8989_3379faa5-91bf-90cf-e063-6394a90aa096
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluoxetine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203836
Marketing category
ANDA
Marketing start
2016-08-22
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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui313990

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
63629-8989-1fluoxetine hydrochloride60 in 1 BOTTLE, PLASTICTABLET, COATED60101
63629-8989-2fluoxetine hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED90101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8989-1EA - Each63629-8989d469c919-b96a-4224-a9ed-9b1916962f9412022-04-06
63629-8989-2EA - Each63629-898993215d49-fdae-4427-9669-1bf13878563512022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8989FLUOXETINE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 2 package rows20250425_80816531-9db3-492b-aebc-4681bf3c1554.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313990FLUoxetine HCl 10 MG Oral TabletPSN80816531-9db3-492b-aebc-4681bf3c1554101
313990fluoxetine 10 MG Oral TabletSCD80816531-9db3-492b-aebc-4681bf3c1554101
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSY80816531-9db3-492b-aebc-4681bf3c1554101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8989-16362989890160 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8989-1) 2021-12-070000-00-00NoNoCurrent
63629-8989-26362989890290 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8989-2) 2021-12-070000-00-00NoNoCurrent