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 7 of 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEBryant Ranch Prepack7553d708-22a0-44ea-b907-7a86f2657f4c2024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBryant Ranch Prepack10293946-5a06-4c21-9f78-941be360b09b2024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECalvin Scott & Co., Inc.4915e22f-cecb-4261-8389-9bb417a20e822024-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBryant Ranch Prepackdced86a0-fc08-465c-897c-f8899e6206d52024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBryant Ranch Prepack493a5946-e750-4500-afd1-8f3fdc1d420e2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.80e52273-9741-6aef-eb24-8a93ead85ba72024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma180a07fd-1f6a-4617-b8e0-f938c65ba2732024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEMedsource Pharmaceuticals1302fc08-d5fa-54b4-e063-6394a90a52752024-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthStar Rx LLC97960730-432e-4e94-bb4e-62a3157270a82024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDETIME CAP LABORATORIES, INC.d7a4db7f-cdac-2b36-e053-2995a90a8d642024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited5336ce59-7a6c-4db9-8512-299cc5e599c02024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited3daecd20-6a59-44d3-8269-4912214c08b42024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited3195db14-0cae-4b49-9fba-49b869fe92a82024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions578ca8f8-86eb-4247-a0b3-50c3837a982e2024-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions08f3c11c-9ba0-4c53-bf31-264725e611ea2023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBluePoint Laboratoriesf89a5800-6fdb-4938-a28e-3bf1aeb1c21a2023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions3fba8d68-0663-4053-93ee-7531246fd47d2023-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEScieGen Pharmaceuticals, Incb5035f61-693e-4386-8a07-3c36a6a469172023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionsa408c325-d2d5-4e88-85ce-96913eb581832023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions224c8c17-0183-4cd7-ab9e-0062f3c624f02023-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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