FDA.reportPublic FDA data

Fluoxetine

Product NDC
16714-112
11-digit product format
167140112
Labeler code
16714
Product ID
16714-112_a3031cb7-423c-64e2-e1d4-2b07f2e7ba3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA076006
Marketing category
ANDA
Marketing start
2019-09-18
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
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
16714-112-01Fluoxetine30 in 1 BOTTLETABLET, FILM COATED303
16714-112-02Fluoxetine100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-112-01EA - Each16714-112d73e8e4a-2050-4606-b5e4-a827eb6bf8dc12020-01-03
16714-112-02EA - Each16714-112a8e4536e-c14d-4819-a5f0-2be32d6e7eb112020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-112FLUOXETINE TABLET, FILM COATED [NORTHSTAR RX LLC]3Current NDC, Legacy NDC, 2 package rows20231020_70b4bd1b-d355-189e-a414-9fff182fd1cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSN70b4bd1b-d355-189e-a414-9fff182fd1cd3
313990FLUoxetine HCl 10 MG Oral TabletPSN70b4bd1b-d355-189e-a414-9fff182fd1cd3
313990fluoxetine 10 MG Oral TabletSCD70b4bd1b-d355-189e-a414-9fff182fd1cd3
248642fluoxetine 20 MG Oral TabletSCD70b4bd1b-d355-189e-a414-9fff182fd1cd3
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSY70b4bd1b-d355-189e-a414-9fff182fd1cd3
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSY70b4bd1b-d355-189e-a414-9fff182fd1cd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-112-011671401120130 TABLET, FILM COATED in 1 BOTTLE (16714-112-01) 2019-09-180000-00-00NoNoCurrent
16714-112-0216714011202100 TABLET, FILM COATED in 1 BOTTLE (16714-112-02) 2019-09-180000-00-00NoNoCurrent