Fluoxetine

Product NDC
60760-311
11-digit product format
607600311
Labeler code
60760
Product ID
60760-311_526abd9c-d474-c5aa-e063-6294a90a4265
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
�St. Mary's Medical Park Pharmacy
Application
ANDA204597
Marketing category
ANDA
Marketing start
2020-06-30
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
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310385

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
60760-311-90Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-311-90EA - Each60760-31146897003-9f27-414c-b38d-4d99acdaa7bc12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-311FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, Legacy NDC, 1 package rows20200710_a9de93d4-2edc-2838-e053-2995a90a8ed6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNa9de93d4-2edc-2838-e053-2995a90a8ed63
310385fluoxetine 20 MG Oral CapsuleSCDa9de93d4-2edc-2838-e053-2995a90a8ed63
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYa9de93d4-2edc-2838-e053-2995a90a8ed63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-311-906076003119090 CAPSULE in 1 BOTTLE, PLASTIC (60760-311-90) 90 capsule2020-06-300000-00-00NoNoCurrent