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 1 of 16 · 308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.a08dadff-f209-48dc-b597-6f085be136402026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEGolden State Medical Supply, Inc.5affa0ea-db84-86fd-e063-6294a90a4d162026-09-08Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.f7ae2dac-6048-41ea-95d3-cad06cc2baf32026-09-03Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingc751ee54-27b4-4ed7-829a-ced735c413122026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingd027f39e-7648-44c8-a8dc-b26b4cdd81be2026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
FluoxetineFLUOXETINE HYDROCHLORIDEMajor Pharmaceuticals76b264ce-2a13-4511-8e21-4ffad0a327f92026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
Inderal XLPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.ac196ff5-9215-402b-bc57-69aa87f8bade2026-08-27Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
InnoPran XLPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.cd5601b3-4d87-4c3b-acac-b476e787609d2026-08-27Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol Hydrochloride ERPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.5415904b-90da-48e8-9f9e-f86749aa129c2026-08-27Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPar Health USA, LLC0d74bb04-8227-4afa-b523-ce1556150e072026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.52da1afc-7f1c-4893-ab84-8479dd9399512026-08-24Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.86c48c5a-0a59-43a7-b3b5-41ab5da72ce12026-08-24Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.582fe781-0759-4622-8fa6-b7d90e94e6962026-08-24Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.1791ef4d-b609-41c8-b4ef-15bff752ddd72026-08-24Warnings, Adverse reactionsExact identifier
application number: ANDA071972
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.d9759182-e681-4c7e-af36-9f7b2184df3c2026-08-24Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856448
unii: F8A3652H1V
INDERAL LAPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.35d28979-36b1-4630-b85e-a44e0a4437342026-08-24Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECreekwood Pharmaceuticals LLC289f39f4-ebd3-4fd9-bbb3-72de8124795a2026-08-21Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
FluoxetineFLUOXETINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.23899405-007b-48d9-82a9-a530b8e907842026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
FLUOXETINEFLUOXETINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.6f4e4e9f-9ded-452f-b3ef-ab6aa9c729522026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.a3bd3ef9-539d-450e-900b-95be0e46095b2026-08-10Warnings, Adverse reactionsExact identifier
application number: ANDA071972
unii: F8A3652H1V

Reported adverse events (FAERS/openFDA)#

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