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 2 of 16 · 301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.1cd914b6-b250-4b11-8404-41db3589361e2026-08-05Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.07c3fcab-33fe-4a6a-ba67-2d042190c1462026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
FluoxetineFLUOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC583c5021-2948-7db4-e063-6294a90ae7dc2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.49d09308-74b0-4f9a-9c03-37234b5ee3a32026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA071972
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC1df7f35e-b1d8-4aca-875e-d197cb61239e2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions1bb6d65a-8264-4fa4-92d4-c4a756ec49ea2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.95a2eacd-b6b7-4e92-ae14-52fbee6c65432026-07-20Warnings, Adverse reactionsExact identifier
application number: ANDA071972
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC63abab85-ec88-4fcf-a8e7-0850e5f797ee2026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
FluoxetineFLUOXETINEREMEDYREPACK INC.24926986-7552-4f1a-8366-f035bbd071042026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackd4043133-38de-4faa-bb76-8fafa59138442026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepacka04a5bed-d051-4bb4-ae20-b09b10d5c1812026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEAmerican Health Packaging7bee936b-0130-4a6b-a974-956aef5486d92026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAmerican Health Packaging9965a672-7842-4926-9063-b76317c748622026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limiteda9ed97dd-8041-4a02-889c-dcb8b2805f362026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited09fb3100-1e06-4cdc-8016-7e4f5d0974902026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.554c7446-8407-460e-b157-f860c5afbf122026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.77b6ae48-8e3a-42e6-9b5a-aeed750861e82026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEMajor Pharmaceuticalse7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba2026-07-14Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856448
unii: F8A3652H1V
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackfb0608d9-1ae3-43be-8a20-e9f34e9558622026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackd5a267cb-08bd-4530-a7a8-2bceddd828e52026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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