FDA.reportPublic FDA data

Fluoxetine

Product NDC
71205-975
11-digit product format
712050975
Labeler code
71205
Product ID
71205-975_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
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
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
71205-975-00Fluoxetine100 in 1 BOTTLECAPSULE1003
71205-975-11Fluoxetine1000 in 1 BOTTLECAPSULE10003
71205-975-30Fluoxetine30 in 1 BOTTLECAPSULE303
71205-975-55Fluoxetine500 in 1 BOTTLECAPSULE5003
71205-975-60Fluoxetine60 in 1 BOTTLECAPSULE603
71205-975-72Fluoxetine120 in 1 BOTTLECAPSULE1203
71205-975-90Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-975-00EA - Each71205-975a9f2876d-4cc5-4ecf-940a-d0b352315a3e12021-06-02
71205-975-11EA - Each71205-975a6c18f63-4518-437b-8376-d23a8ec22ab412021-06-02
71205-975-30EA - Each71205-975f46152fc-6831-4831-8ed8-55d76da27a0212021-06-02
71205-975-55EA - Each71205-9756313c73b-9d71-4716-9d70-12a71db4229a12021-06-02
71205-975-60EA - Each71205-975a06a6613-a3b7-4a10-9034-423c71f7b9c912021-06-02
71205-975-72EA - Each71205-97556450434-5e5f-47cf-92a5-7c4a80e93a0d12021-06-02
71205-975-90EA - Each71205-975cf2c5777-6463-4665-ba11-96b3db2c614112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-975FLUOXETINE (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
71205-975-0071205097500100 CAPSULE in 1 BOTTLE (71205-975-00) 100 capsule2020-05-070000-00-00NoNoCurrent
71205-975-11712050975111000 CAPSULE in 1 BOTTLE (71205-975-11) 1000 capsule2020-05-070000-00-00NoNoCurrent
71205-975-307120509753030 CAPSULE in 1 BOTTLE (71205-975-30) 30 capsule2020-05-070000-00-00NoNoCurrent
71205-975-5571205097555500 CAPSULE in 1 BOTTLE (71205-975-55) 500 capsule2020-05-070000-00-00NoNoCurrent
71205-975-607120509756060 CAPSULE in 1 BOTTLE (71205-975-60) 60 capsule2020-05-070000-00-00NoNoCurrent
71205-975-7271205097572120 CAPSULE in 1 BOTTLE (71205-975-72) 120 capsule2020-05-070000-00-00NoNoCurrent
71205-975-907120509759090 CAPSULE in 1 BOTTLE (71205-975-90) 90 capsule2020-05-070000-00-00NoNoCurrent