FDA.reportPublic FDA data

Fluoxetine

Product NDC
71205-979
11-digit product format
712050979
Labeler code
71205
Product ID
71205-979_14464dfb-94a5-43a1-923e-d462b7ade131
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204597
Marketing category
ANDA
Marketing start
2019-09-25
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
71205-979-00Fluoxetine100 in 1 BOTTLECAPSULE1003
71205-979-11Fluoxetine1000 in 1 BOTTLECAPSULE10003
71205-979-30Fluoxetine30 in 1 BOTTLECAPSULE303
71205-979-55Fluoxetine500 in 1 BOTTLECAPSULE5003
71205-979-60Fluoxetine60 in 1 BOTTLECAPSULE603
71205-979-72Fluoxetine120 in 1 BOTTLECAPSULE1203
71205-979-90Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-979-00EA - Each71205-979ea223e24-61ce-4ca7-abb1-0dfbd188b58212021-06-02
71205-979-11EA - Each71205-9792377d8d2-5bc9-4b0d-9935-c295fa4f390712021-06-02
71205-979-30EA - Each71205-979a15478ca-b2ef-4d6a-82fa-05ab9d1be01412021-06-02
71205-979-55EA - Each71205-9790f8cce83-0a08-4c72-99c2-cd4918f8f79212021-06-02
71205-979-60EA - Each71205-9791176be5b-d051-4444-827f-f4791ddf395f12021-06-02
71205-979-72EA - Each71205-9795ecdc14e-0bf3-4ae8-8e41-68c8f0f9fe0912021-06-02
71205-979-90EA - Each71205-979bde73227-1b10-4fbc-88b3-72aa9351134512021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-979FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 7 package rows20220402_57f21f2b-0ec2-49dc-911a-806e5ae880c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSN57f21f2b-0ec2-49dc-911a-806e5ae880c23
310385FLUoxetine 20 MG Oral CapsulePSN57f21f2b-0ec2-49dc-911a-806e5ae880c23
313989FLUoxetine 40 MG Oral CapsulePSN57f21f2b-0ec2-49dc-911a-806e5ae880c23
310384fluoxetine 10 MG Oral CapsuleSCD57f21f2b-0ec2-49dc-911a-806e5ae880c23
310385fluoxetine 20 MG Oral CapsuleSCD57f21f2b-0ec2-49dc-911a-806e5ae880c23
313989fluoxetine 40 MG Oral CapsuleSCD57f21f2b-0ec2-49dc-911a-806e5ae880c23
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSY57f21f2b-0ec2-49dc-911a-806e5ae880c23
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY57f21f2b-0ec2-49dc-911a-806e5ae880c23
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY57f21f2b-0ec2-49dc-911a-806e5ae880c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-979-0071205097900100 CAPSULE in 1 BOTTLE (71205-979-00) 100 capsule2020-05-070000-00-00NoNoCurrent
71205-979-11712050979111000 CAPSULE in 1 BOTTLE (71205-979-11) 1000 capsule2020-05-070000-00-00NoNoCurrent
71205-979-307120509793030 CAPSULE in 1 BOTTLE (71205-979-30) 30 capsule2020-05-070000-00-00NoNoCurrent
71205-979-5571205097955500 CAPSULE in 1 BOTTLE (71205-979-55) 500 capsule2020-05-070000-00-00NoNoCurrent
71205-979-607120509796060 CAPSULE in 1 BOTTLE (71205-979-60) 60 capsule2020-05-070000-00-00NoNoCurrent
71205-979-7271205097972120 CAPSULE in 1 BOTTLE (71205-979-72) 120 capsule2020-05-070000-00-00NoNoCurrent
71205-979-907120509799090 CAPSULE in 1 BOTTLE (71205-979-90) 90 capsule2020-05-070000-00-00NoNoCurrent