FDA.reportPublic FDA data

NDC 67046-211-03 - Fluoxetine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67046-211
Requested NDC
67046-211-03
Package NDCs from labels
67046-211-30, 67046-211-60, 67046-211-03
Manufacturer
Contract Pharmacy Services-PA
Effective date
2010-04-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine Hydrochloride - Contract Pharmacy Services-PAContract Pharmacy Services-PA2010-04-05HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 15 · 292 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEQPharma Inc50253c6e-de36-05e6-e063-6294a90ad7a82026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECoupler LLC5386a140-7c5b-5959-e063-6294a90a2ad02026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack992060ee-fb4e-4c6d-9ffe-30902bc63af22026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEPar Health USA, LLC53ac797d-8792-4a8c-9708-d1de3d377e8f2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack4dd23053-0458-40f2-ac34-afb8cc9903aa2026-05-27Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
FluoxetineFLUOXETINE HYDROCHLORIDESt. Mary's Medical Park Pharmacya9de93d4-2edc-2838-e053-2995a90a8ed62026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEPD-Rx Pharmaceuticals, Inc.5dc20c8f-0d8f-400c-b850-fe1b7e3e75e32026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEPD-Rx Pharmaceuticals, Inc.51b8e791-4e9a-4014-b4d8-68fd51ca889f2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEProficient Rx LP1a2a5194-b793-4c62-a177-040dad38526b2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7d7a196b-91de-4753-8bb6-c6d5c668952d2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECoupler LLC5020d0d6-969e-b4cd-e063-6294a90af9d22026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEREMEDYREPACK INC.d1c768b5-64bb-4036-aa92-797b3a5f92eb2026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINECoupler LLC50117d4f-0777-54d3-e063-6394a90a857c2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINENorthwind Health Company, LLC50369762-c7c3-d58e-e063-6294a90af8df2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ef0fa849-a3a0-45d2-9258-da2d46bee0892026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ec608267-9c00-4d5c-a9ed-d89503f93d282026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.e83e2220-d32a-472c-bd9f-b87d0cf8858f2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FLUOXETINEFLUOXETINEPreferred Pharmaceuticals Inc.54ded68c-1d2e-453d-b155-84c3102e1f0e2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEA-S Medication Solutions679e439a-d955-4b54-8236-a2ccd9a2a10a2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEA-S Medication Solutions3ce2f189-4386-4d0d-84f6-6d913ad1c09b2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.