FDA.reportPublic FDA data

Fluoxetine

Product NDC
68001-401
11-digit product format
680010401
Labeler code
68001
Product ID
68001-401_0c3d632c-6b3e-4e78-e063-6394a90a7ed2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078619
Marketing category
ANDA
Marketing start
2019-06-19
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384, 310385, 313989

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
68001-401-00Fluoxetine100 in 1 BOTTLECAPSULE1007
68001-401-03Fluoxetine500 in 1 BOTTLECAPSULE5007
68001-401-04Fluoxetine30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-401-00EA - Each68001-401e0a120a0-a69b-4895-9db6-2c1d413758c712019-10-07
68001-401-03EA - Each68001-4017a583448-4331-4fcd-a372-d576f7fcc1bd12019-10-07
68001-401-04EA - Each68001-4017fed4e2a-8b0d-42c1-be6a-403679e8558812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-401FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 3 package rows20231212_f89a5800-6fdb-4938-a28e-3bf1aeb1c21a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
310385FLUoxetine 20 MG Oral CapsulePSNf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
313989FLUoxetine 40 MG Oral CapsulePSNf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
310384fluoxetine 10 MG Oral CapsuleSCDf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
310385fluoxetine 20 MG Oral CapsuleSCDf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
313989fluoxetine 40 MG Oral CapsuleSCDf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYf89a5800-6fdb-4938-a28e-3bf1aeb1c21a7
313989FLUoxetine 40 MG Oral CapsulePSN7bee936b-0130-4a6b-a974-956aef5486d93
313989fluoxetine 40 MG Oral CapsuleSCD7bee936b-0130-4a6b-a974-956aef5486d93
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY7bee936b-0130-4a6b-a974-956aef5486d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-401-0068001040100100 CAPSULE in 1 BOTTLE (68001-401-00) 100 capsule2019-06-190000-00-00NoNoCurrent
68001-401-0368001040103500 CAPSULE in 1 BOTTLE (68001-401-03) 500 capsule2019-06-190000-00-00NoNoCurrent
68001-401-046800104010430 CAPSULE in 1 BOTTLE (68001-401-04) 30 capsule2019-06-190000-00-00NoNoCurrent