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 8 of 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEUpsher-Smith Laboratories, LLCbe2e4325-feb9-4957-99c0-0a741a2d71a02023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionsc4eeae3d-ae56-4e7e-b07d-02851f12039f2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEMARKSANS PHARMA LIMITED8e822937-9431-446f-88c4-330a25d124392023-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs9f069b9b-16e4-4f0e-b420-4aa02ffbb6322023-09-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEDr.Reddy's Laboratories Limited11544dea-2f5e-1536-584a-5d1f37a997702023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDELannett Company, Inc.c856d72f-4a1a-4f75-ae54-c4ac83ddcfa12023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionsa5d49dee-a7de-44d8-80b5-1aeb89e769382023-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINETeva Pharmaceuticals USA, Inc.06d71a33-5578-4012-b11d-764f45bc1e6a2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECalvin Scott & Co., Inc.3453755b-3ed6-47a3-b4c7-c64758e7784c2023-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAlembic Pharmaceuticals Limited6b9c2d73-866b-44c4-8718-e7e4a9a0fb552023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEProficient Rx LPef699ed0-fd9e-4580-93bb-6fd50499dbd12022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEProficient Rx LP57f21f2b-0ec2-49dc-911a-806e5ae880c22022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEProficient Rx LPa6457d6e-5586-40e9-883d-352ee0527d802021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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