FDA.reportPublic FDA data

Fluoxetine

Product NDC
0121-4721
11-digit product format
001214721
Labeler code
0121
Product ID
0121-4721_12f427c0-a74a-4af5-ad77-7282d4d70190
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA076015
Marketing category
ANDA
Marketing start
2002-02-01
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
0121-4721-05Fluoxetine5 mL in 1 CUP, UNIT-DOSESOLUTION513
0121-4721-40Fluoxetine10 in 1 TRAYSOLUTION1013
0121-4721-40Fluoxetine4 in 1 CASESOLUTION413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4721-05ML - Milliliter0121-4721b3a1acee-f46d-489a-a050-3da690e7ab4712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4721FLUOXETINE (FLUOXETINE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]13Current NDC, Legacy NDC, 3 package rows20240328_180a07fd-1f6a-4617-b8e0-f938c65ba273.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310386FLUoxetine 20 MG in 5 mL Oral SolutionPSN180a07fd-1f6a-4617-b8e0-f938c65ba27313
310386fluoxetine 4 MG/ML Oral SolutionSCD180a07fd-1f6a-4617-b8e0-f938c65ba27313
310386fluoxetine 20 MG per 5 ML Oral SolutionSY180a07fd-1f6a-4617-b8e0-f938c65ba27313
310386fluoxetine 4 MG/ML (as fluoxetine HCl) Oral SolutionSY180a07fd-1f6a-4617-b8e0-f938c65ba27313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-4721-05001214721055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-4721-40001214721404 TRAY in 1 CASE (0121-4721-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4721-05) 4 tray2002-02-010000-00-00NoNoCurrent