Fluoxetine

Product NDC
68999-730
11-digit product format
689990730
Labeler code
68999
Product ID
68999-730_4a935e59-bd47-9aae-e063-6394a90aad58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
LIQUID
Route
ORAL
Labeler
Chartwell Governmental & Specialty 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
68999-730-24Fluoxetine10 in 1 TRAYLIQUID102
68999-730-24Fluoxetine2 in 1 BOXLIQUID22
68999-730-45Fluoxetine5 mL in 1 CUPLIQUID52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-730-24ML - Milliliter68999-73033d71271-5f30-4375-8fbe-d89d02904bba12026-02-05
68999-730-45ML - Milliliter68999-7307c7e923c-43c9-4704-8036-fee427cfb87d12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310386FLUoxetine 20 MG in 5 mL Oral SolutionPSNd34362ed-e821-4c55-9f8c-3dfb772b1b2a2
310386fluoxetine 4 MG/ML Oral SolutionSCDd34362ed-e821-4c55-9f8c-3dfb772b1b2a2
310386fluoxetine 20 MG per 5 ML Oral SolutionSYd34362ed-e821-4c55-9f8c-3dfb772b1b2a2
310386fluoxetine 4 MG/ML (as fluoxetine HCl) Oral SolutionSYd34362ed-e821-4c55-9f8c-3dfb772b1b2a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-730-24689990730242 TRAY in 1 BOX (68999-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-730-45) 2 tray2025-10-31NoNoHistorical
68999-730-45689990730455 mL in 1 CUP5 mlHistorical