Fluoxetine Hydrochloride

Product NDC
67046-211
11-digit product format
670460211
Labeler code
67046
Product ID
67046-211_4e4d8017-9c1d-41eb-affb-8046e3548be9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA075245
Marketing category
ANDA
Marketing start
2010-04-05
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-211-302019-10-21C16284748780-1956f9ecf-c1e0-621f-e053-dbdaa90a74adFLUOXETINE CAPSULES USP Rx only 4356
67046-211-602019-10-21C16284748780-1956f9ecf-c1e0-621f-e053-dbdaa90a74adFLUOXETINE CAPSULES USP Rx only 4356

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-211-30Fluoxetine Hydrochloride30 in 1 BLISTER PACKCAPSULE301
67046-211-60Fluoxetine Hydrochloride60 in 1 BLISTER PACKCAPSULE601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluoxetine hydrochlorideACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
fluoxetineACTIVE MOIETY01K63SUP8DFLUOXETINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-211FLUOXETINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 2 package rows20100406_4e4d8017-9c1d-41eb-affb-8046e3548be9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN4e4d8017-9c1d-41eb-affb-8046e3548be91
310385fluoxetine 20 MG Oral CapsuleSCD4e4d8017-9c1d-41eb-affb-8046e3548be91
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY4e4d8017-9c1d-41eb-affb-8046e3548be91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-211-306704602113030 in 1 BLISTER PACKHistorical
67046-211-606704602116060 in 1 BLISTER PACKHistorical