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 4 of 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProzacFLUOXETINE HYDROCHLORIDEDista Products Companyc88f33ed-6dfb-4c5e-bc01-d8e36dd972992026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Fluoxetine HydrochlorideFLUOXETINE HYDROCHLORIDEANI Pharmaceuticals, Inc.1ffe57c3-6f70-4075-aacb-d87a3990fdea2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCda6b9b19-2ea1-9a39-e053-2995a90ad7302026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCdfae4357-b6f9-9a30-e053-2995a90a26672026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCaae4e339-5244-f6f9-e053-2995a90a42ce2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCab1eec9d-f755-81a2-e053-2a95a90acb3c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCf2a48124-0790-51c2-e053-2a95a90aa1af2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCcb66a702-7670-4a73-98fb-0e63151a1ffb2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Olanzapine and FluoxetineOLANZAPINE AND FUOXETINEPar Health USA, LLC2f6ceda3-3edc-4427-98a6-23e3c930c44d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEQPharma Incb4831735-6731-473a-b4f0-1f4a67aa71202025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEQPharma Incfc754dff-cecb-fc6b-e053-6394a90ab3712025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionscdf3b608-e14c-474b-b80e-01ac5f7018662025-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionscca9edf9-2454-4bf9-98e8-c531a8f5dc422025-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Olanzapine and FluoxetineOLANZAPINE AND FLUOXETINEAvKAREf5f78ed2-4640-8528-c51c-d7bffa045d482025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBryant Ranch Prepackc1c7ec04-dd9e-400f-8f49-e900945fc61c2025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECardinal Health 107, LLC06394c4b-99f4-4257-bf29-53c170c5a0612025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINETeva Pharmaceuticals USA, Inc.369dbfba-9de4-433c-8680-2ec047b8f8d92025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDECouplerLLC3e111be4-28f0-c290-e063-6294a90a447f2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.3e8912e2-2a0c-5047-e063-6294a90a7e322025-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEQUALLENT PHARMACEUTICALS HEALTH LLC4abbd9d9-e9b1-463d-8f39-f3f50d80f58a2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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