FDA.reportPublic FDA data

NDC 49427-343 - RECONCILE

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
49427-343
Package NDCs from labels
49427-343-57, 49427-343-44
Manufacturer
Pegasus Laboratories, Inc.
Effective date
2022-12-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RECONCILE - Pegasus Laboratories, Inc.Pegasus Laboratories, Inc.2022-12-29PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49427-343-44RECONCILE90 in 1 BOTTLETABLET, CHEWABLE903
49427-343-57RECONCILE30 in 1 BOTTLETABLET, CHEWABLE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49427-343RECONCILE (FLUOXETINE HYDROCHLORIDE) TABLET, CHEWABLE [PEGASUS LABORATORIES, INC.]32 package rows20221230_7dd5d1f2-ea05-4885-be93-c0d12c5eeca7.zip

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 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack023cef65-c9c2-4d70-af66-198fb1b577142026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Fluoxetine HCLFLUOXETINE HCLDirect_rx48705e4f-c3ee-af78-e063-6394a90ad0522026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEQPharma Inc50253c6e-de36-05e6-e063-6294a90ad7a82026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
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
FluoxetineFLUOXETINE HYDROCHLORIDESt. Mary's Medical Park Pharmacya9de93d4-2edc-2838-e053-2995a90a8ed62026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
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
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
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
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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