FDA.reportPublic FDA data

Fluoxetine

Product NDC
49483-703
11-digit product format
494830703
Labeler code
49483
Product ID
49483-703_22f2136b-5f0f-f6c7-e063-6394a90a907c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC.
Application
ANDA075465
Marketing category
ANDA
Marketing start
2022-02-12
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384, 310385, 313989

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
49483-703-01Fluoxetine100 in 1 BOTTLECAPSULE1006
49483-703-03Fluoxetine30 in 1 BOTTLECAPSULE306
49483-703-50Fluoxetine500 in 1 BOTTLECAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-703-01EA - Each49483-70367978061-1270-4561-b1d8-14f665d9cba412022-06-06
49483-703-03EA - Each49483-703fb2567a4-c827-4d56-884d-00660432837812022-06-06
49483-703-50EA - Each49483-703b4dd6b5a-8ec5-4433-880d-062753e7db8f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-703FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TIME CAP LABORATORIES, INC.]6Current NDC, Legacy NDC, 3 package rows20240927_d7a4db7f-cdac-2b36-e053-2995a90a8d64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNd7a4db7f-cdac-2b36-e053-2995a90a8d646
310385FLUoxetine 20 MG Oral CapsulePSNd7a4db7f-cdac-2b36-e053-2995a90a8d646
313989FLUoxetine 40 MG Oral CapsulePSNd7a4db7f-cdac-2b36-e053-2995a90a8d646
310384fluoxetine 10 MG Oral CapsuleSCDd7a4db7f-cdac-2b36-e053-2995a90a8d646
310385fluoxetine 20 MG Oral CapsuleSCDd7a4db7f-cdac-2b36-e053-2995a90a8d646
313989fluoxetine 40 MG Oral CapsuleSCDd7a4db7f-cdac-2b36-e053-2995a90a8d646
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYd7a4db7f-cdac-2b36-e053-2995a90a8d646
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYd7a4db7f-cdac-2b36-e053-2995a90a8d646
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYd7a4db7f-cdac-2b36-e053-2995a90a8d646
313989FLUoxetine 40 MG Oral CapsulePSNf2a48124-0790-51c2-e053-2a95a90aa1af4
313989fluoxetine 40 MG Oral CapsuleSCDf2a48124-0790-51c2-e053-2a95a90aa1af4
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYf2a48124-0790-51c2-e053-2a95a90aa1af4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-703-0149483070301100 CAPSULE in 1 BOTTLE (49483-703-01) 100 capsule2022-02-120000-00-00NoNoCurrent
49483-703-034948307030330 CAPSULE in 1 BOTTLE (49483-703-03) 30 capsule2022-02-120000-00-00NoNoCurrent
49483-703-5049483070350500 CAPSULE in 1 BOTTLE (49483-703-50) 500 capsule2022-02-120000-00-00NoNoCurrent