Fluoxetine

Product NDC
71335-2020
11-digit product format
713352020
Labeler code
71335
Product ID
71335-2020_c282532b-eca5-434b-8101-34f75853cc3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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
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/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
71335-2020-1Fluoxetine30 in 1 BOTTLECAPSULE30104
71335-2020-2Fluoxetine100 in 1 BOTTLECAPSULE100104
71335-2020-3Fluoxetine60 in 1 BOTTLECAPSULE60104
71335-2020-4Fluoxetine15 in 1 BOTTLECAPSULE15104
71335-2020-5Fluoxetine56 in 1 BOTTLECAPSULE56104
71335-2020-6Fluoxetine28 in 1 BOTTLECAPSULE28104
71335-2020-7Fluoxetine90 in 1 BOTTLECAPSULE90104
71335-2020-8Fluoxetine120 in 1 BOTTLECAPSULE120104
71335-2020-9Fluoxetine45 in 1 BOTTLECAPSULE45104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2020-1EA - Each71335-20200b771816-972a-4613-9dd4-957e3a683a0a12023-09-05
71335-2020-2EA - Each71335-2020948d902c-dc49-4e90-9fea-8640965520ee12023-12-05
71335-2020-3EA - Each71335-2020f076a2b9-3f13-4fdc-a5f8-08c9cf81e6f012023-12-05
71335-2020-7EA - Each71335-2020192cafc3-89e2-4872-85ae-b846b709d28112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2020FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 9 package rows20240824_3d5d03ff-0d0c-429f-b747-31ff3465d39d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN3d5d03ff-0d0c-429f-b747-31ff3465d39d104
310385fluoxetine 20 MG Oral CapsuleSCD3d5d03ff-0d0c-429f-b747-31ff3465d39d104
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY3d5d03ff-0d0c-429f-b747-31ff3465d39d104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2020-17133520200130 CAPSULE in 1 BOTTLE (71335-2020-1) 30 capsule2022-01-240000-00-00NoNoCurrent
71335-2020-271335202002100 CAPSULE in 1 BOTTLE (71335-2020-2) 100 capsule2023-01-240000-00-00NoNoCurrent
71335-2020-37133520200360 CAPSULE in 1 BOTTLE (71335-2020-3) 60 capsule2021-12-220000-00-00NoNoCurrent
71335-2020-47133520200415 CAPSULE in 1 BOTTLE (71335-2020-4) 15 capsule2024-07-150000-00-00NoNoCurrent
71335-2020-57133520200556 CAPSULE in 1 BOTTLE (71335-2020-5) 56 capsule2024-07-150000-00-00NoNoCurrent
71335-2020-67133520200628 CAPSULE in 1 BOTTLE (71335-2020-6) 28 capsule2024-07-150000-00-00NoNoCurrent
71335-2020-77133520200790 CAPSULE in 1 BOTTLE (71335-2020-7) 90 capsule2022-01-180000-00-00NoNoCurrent
71335-2020-871335202008120 CAPSULE in 1 BOTTLE (71335-2020-8) 120 capsule2024-07-150000-00-00NoNoCurrent
71335-2020-97133520200945 CAPSULE in 1 BOTTLE (71335-2020-9) 45 capsule2024-07-150000-00-00NoNoCurrent