FDA.reportPublic FDA data

NDC 80425-0313-01 - Fluoxetine

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
80425-0313
Requested NDC
80425-0313-01
Package NDCs from labels
80425-0313-1, 80425-0313-2, 80425-0313-3, 80425-0313-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0313-1Fluoxetine30 in 1 BOTTLECAPSULE302
80425-0313-2Fluoxetine60 in 1 BOTTLECAPSULE602
80425-0313-3Fluoxetine90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0313FLUOXETINE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f917063a-226e-0978-e053-6294a90aeb4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0313-1EA - Each80425-0313b8d1d31a-fff6-4b9c-a9b3-e011b8c7eb4712023-06-06
80425-0313-2EA - Each80425-0313829bc627-e21e-4aa1-99b3-4b8ba39cdb6f12023-06-06
80425-0313-3EA - Each80425-0313562d5109-ba29-492b-84e6-90b21d9adfc712023-06-06

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 8 of 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionsa5d49dee-a7de-44d8-80b5-1aeb89e769382023-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINETeva Pharmaceuticals USA, Inc.06d71a33-5578-4012-b11d-764f45bc1e6a2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
Fluoxetine HydrochlorideFLUOXETINE HYDROCHLORIDELupin Pharmaceuticals, Inc.dd659085-c32d-4d35-9d4b-bafa2a93f1fb2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAlembic Pharmaceuticals Inc.e9ee6e93-4a57-4fd1-a417-3944484dd32c2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEDr.Reddy's Laboratories Inc.390c61e6-14dd-4391-45b8-0fb5f46527232023-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINENorthStar Rx LLC70b4bd1b-d355-189e-a414-9fff182fd1cd2023-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC06582152-d7d3-4e87-8c13-a4416a6ec9272023-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECalvin Scott & Co., Inc.3453755b-3ed6-47a3-b4c7-c64758e7784c2023-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310384
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAlembic Pharmaceuticals Limited6b9c2d73-866b-44c4-8718-e7e4a9a0fb552023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
Fluoxetine HydrochlorideFLUOXETINE HYDROCHLORIDEAlembic Pharmaceuticals Limited9c5112c0-c721-4086-9a75-3b7f931430bb2023-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEProficient Rx LP70e115cc-6e9b-4b96-a1a9-779ed51ad0a72022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEProficient Rx LPef699ed0-fd9e-4580-93bb-6fd50499dbd12022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEProficient Rx LP57f21f2b-0ec2-49dc-911a-806e5ae880c22022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEProficient Rx LPa6457d6e-5586-40e9-883d-352ee0527d802021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 313989
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEProficient Rx LP0cba1992-3990-42a1-9d9a-77b593bbb02e2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack02283de9-6087-45f7-a9ce-3b082ce860de2019-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEVensun Pharmaceuticals, Inc.b4f37ef1-8f5e-4318-90f1-2d8f8afb669c2017-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204597
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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