FDA.reportPublic FDA data

Fluoxetine

Product NDC
60687-845
11-digit product format
606870845
Labeler code
60687
Product ID
60687-845_31f54f70-b632-cb9e-e063-6394a90a329f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA079209
Marketing category
ANDA
Marketing start
2024-12-04
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
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/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
60687-845-40Fluoxetine5 mL in 1 CUP, UNIT-DOSESOLUTION53
60687-845-46Fluoxetine10 in 1 TRAYSOLUTION103
60687-845-77Fluoxetine4 in 1 CASESOLUTION43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-845-40ML - Milliliter60687-8458e325828-d22c-4ca3-8c30-77cbdee41ae112024-11-05
60687-845-77ML - Milliliter60687-845503abff8-ff0b-48e3-80d2-73be67210ea812024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-845FLUOXETINE SOLUTION [AMERICAN HEALTH PACKAGING]3Current NDC, 3 package rows20250406_3276a2a4-61c7-4de6-b519-3aa8b62da88f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310386FLUoxetine 20 MG in 5 mL Oral SolutionPSN3276a2a4-61c7-4de6-b519-3aa8b62da88f3
310386fluoxetine 4 MG/ML Oral SolutionSCD3276a2a4-61c7-4de6-b519-3aa8b62da88f3
310386fluoxetine 20 MG per 5 ML Oral SolutionSY3276a2a4-61c7-4de6-b519-3aa8b62da88f3
310386fluoxetine 4 MG/ML (as fluoxetine HCl) Oral SolutionSY3276a2a4-61c7-4de6-b519-3aa8b62da88f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-845-40606870845405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-845-466068708454610 in 1 TRAYHistorical
60687-845-77606870845774 TRAY in 1 CASE (60687-845-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-845-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-845-40) 4 tray2024-12-04NoNoCurrent