FDA.reportPublic FDA data

Fluoxetine

Product NDC
62135-730
11-digit product format
621350730
Labeler code
62135
Product ID
62135-730_4a16df46-6bfb-37c2-e063-6394a90a9525
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
LIQUID
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA076458
Marketing category
ANDA
Marketing start
2004-05-14
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/5mL
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310386

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-730-24Fluoxetine10 in 1 TRAYLIQUID105
62135-730-24Fluoxetine2 in 1 BOXLIQUID25
62135-730-41Fluoxetine120 mL in 1 BOTTLELIQUID1205
62135-730-45Fluoxetine5 mL in 1 CUPLIQUID55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-730FLUOXETINE LIQUID [CHARTWELL RX, LLC]3Current NDC, 4 package rows20240526_cac17277-3481-4661-935f-efc48fff534c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310386FLUoxetine 20 MG in 5 mL Oral SolutionPSNcac17277-3481-4661-935f-efc48fff534c5
310386fluoxetine 4 MG/ML Oral SolutionSCDcac17277-3481-4661-935f-efc48fff534c5
310386fluoxetine 20 MG per 5 ML Oral SolutionSYcac17277-3481-4661-935f-efc48fff534c5
310386fluoxetine 4 MG/ML (as fluoxetine HCl) Oral SolutionSYcac17277-3481-4661-935f-efc48fff534c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-730-24621350730242 TRAY in 1 BOX (62135-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-730-45) 2 tray2024-05-23NoNoCurrent
62135-730-4162135073041120 mL in 1 BOTTLE (62135-730-41) 120 ml2023-09-27NoNoCurrent
62135-730-45621350730455 mL in 1 CUP5 mlHistorical