FDA.reportPublic FDA data

fluoxetine hydrochloride

Product NDC
63629-2197
11-digit product format
636292197
Labeler code
63629
Product ID
63629-2197_02a9b206-9ae1-051e-e063-6294a90afc5c
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
63629-2197-1fluoxetine hydrochloride30 in 1 BOTTLE, PLASTICTABLET, COATED30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2197-1EA - Each63629-2197440245ff-ff0d-44fe-bdae-ca50dcb5ed7912021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2197FLUOXETINE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20230812_fb0608d9-1ae3-43be-8a20-e9f34e955862.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313990FLUoxetine HCl 10 MG Oral TabletPSNfb0608d9-1ae3-43be-8a20-e9f34e955862103
313990fluoxetine 10 MG Oral TabletSCDfb0608d9-1ae3-43be-8a20-e9f34e955862103
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSYfb0608d9-1ae3-43be-8a20-e9f34e955862103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2197-16362921970130 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-2197-1) 2016-08-220000-00-00NoNoCurrent