FDA.reportPublic FDA data

Fluoxetine

Product NDC
49483-702
11-digit product format
494830702
Labeler code
49483
Product ID
49483-702_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
20 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 HYDROCHLORIDE20 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
49483-702-01Fluoxetine100 in 1 BOTTLECAPSULE1006
49483-702-10Fluoxetine1000 in 1 BOTTLECAPSULE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-702-01EA - Each49483-702e476522d-3776-44c9-b03e-b1681f36852c12022-06-06
49483-702-10EA - Each49483-7025b7f6513-3b23-40e4-8335-b64ec6226f9312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-702FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [TIME CAP LABORATORIES, INC.]6Current NDC, Legacy NDC, 2 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-702-0149483070201100 CAPSULE in 1 BOTTLE (49483-702-01) 100 capsule2022-02-120000-00-00NoNoCurrent
49483-702-10494830702101000 CAPSULE in 1 BOTTLE (49483-702-10) 1000 capsule2022-02-120000-00-00NoNoCurrent