FDA.reportPublic FDA data

FLUOXETINE HYDROCHLORIDE

Product NDC
51672-5306
11-digit product format
516725306
Labeler code
51672
Product ID
51672-5306_135b375a-b00e-72c3-e063-6394a90af4f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA211477
Marketing category
ANDA
Marketing start
2019-02-15
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui1190110

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
51672-5306-2FLUOXETINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5005
51672-5306-6FLUOXETINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5306-6EA - Each51672-5306bf903a95-495e-4e12-b803-947fd15d8a3612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5306FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 2 package rows20240312_77b6ae48-8e3a-42e6-9b5a-aeed750861e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190110FLUoxetine HCl 60 MG Oral TabletPSN77b6ae48-8e3a-42e6-9b5a-aeed750861e85
1190110fluoxetine 60 MG Oral TabletSCD77b6ae48-8e3a-42e6-9b5a-aeed750861e85
1190110fluoxetine (as fluoxetine HCl) 60 MG Oral TabletSY77b6ae48-8e3a-42e6-9b5a-aeed750861e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-5306-251672530602500 TABLET, FILM COATED in 1 BOTTLE (51672-5306-2) 2019-02-150000-00-00NoNoCurrent
51672-5306-65167253060630 TABLET, FILM COATED in 1 BOTTLE (51672-5306-6) 2019-02-150000-00-00NoNoCurrent