FDA.reportPublic FDA data

Fluoxetine Hydrochloride

Product NDC
68180-998
11-digit product format
681800998
Labeler code
68180
Product ID
68180-998_71041a6b-43e4-415c-a1a6-dbd55a09a0d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA211653
Marketing category
ANDA
Marketing start
2019-08-07
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
Rxcui248642, 313990

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-998-01Fluoxetine Hydrochloride100 in 1 BOTTLETABLET10010
68180-998-06Fluoxetine Hydrochloride30 in 1 BOTTLETABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-998-01EA - Each68180-99837b465b3-b853-4430-9ab6-dad993262e1d12019-07-02
68180-998-06EA - Each68180-998faf4c13d-8505-4325-9c00-2a2de647eaa412019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-998FLUOXETINE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20230810_dd659085-c32d-4d35-9d4b-bafa2a93f1fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSNdd659085-c32d-4d35-9d4b-bafa2a93f1fb10
313990FLUoxetine HCl 10 MG Oral TabletPSNdd659085-c32d-4d35-9d4b-bafa2a93f1fb10
313990fluoxetine 10 MG Oral TabletSCDdd659085-c32d-4d35-9d4b-bafa2a93f1fb10
248642fluoxetine 20 MG Oral TabletSCDdd659085-c32d-4d35-9d4b-bafa2a93f1fb10
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSYdd659085-c32d-4d35-9d4b-bafa2a93f1fb10
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSYdd659085-c32d-4d35-9d4b-bafa2a93f1fb10
313990FLUoxetine HCl 10 MG Oral TabletPSN2260e921-26e7-4696-8ef7-f2d73590761b2
313990fluoxetine 10 MG Oral TabletSCD2260e921-26e7-4696-8ef7-f2d73590761b2
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSY2260e921-26e7-4696-8ef7-f2d73590761b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-998-0168180099801100 TABLET in 1 BOTTLE (68180-998-01) 100 tablet2019-08-070000-00-00NoNoCurrent
68180-998-066818009980630 TABLET in 1 BOTTLE (68180-998-06) 30 tablet2019-08-070000-00-00NoNoCurrent