FDA.reportPublic FDA data

Fluoxetine Hydrochloride

Product NDC
46708-242
11-digit product format
467080242
Labeler code
46708
Product ID
46708-242_563f5910-59e7-46c6-9b3d-d9c9b0efb350
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA208698
Marketing category
ANDA
Marketing start
2017-04-15
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
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
46708-242-30Fluoxetine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
46708-242-31Fluoxetine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
46708-242-91Fluoxetine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-242FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 3 package rows20230126_9c5112c0-c721-4086-9a75-3b7f931430bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSN9c5112c0-c721-4086-9a75-3b7f931430bb5
313990FLUoxetine HCl 10 MG Oral TabletPSN9c5112c0-c721-4086-9a75-3b7f931430bb5
313990fluoxetine 10 MG Oral TabletSCD9c5112c0-c721-4086-9a75-3b7f931430bb5
248642fluoxetine 20 MG Oral TabletSCD9c5112c0-c721-4086-9a75-3b7f931430bb5
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSY9c5112c0-c721-4086-9a75-3b7f931430bb5
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSY9c5112c0-c721-4086-9a75-3b7f931430bb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-242-304670802423030 TABLET, FILM COATED in 1 BOTTLE (46708-242-30) 2017-04-150000-00-00NoNoCurrent
46708-242-3146708024231100 TABLET, FILM COATED in 1 BOTTLE (46708-242-31) 2017-04-150000-00-00NoNoCurrent
46708-242-91467080242911000 TABLET, FILM COATED in 1 BOTTLE (46708-242-91) 2017-04-150000-00-00NoNoCurrent