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 5 of 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEBryant Ranch Prepack97e7929f-dec4-467d-93c2-93360884e9e92025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FLUOXETINEFLUOXETINEBryant Ranch Prepack651e8c32-4519-4619-854f-4be03c6240b62025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINENCS HealthCare of KY, LLC dba Vangard Labs647e17f5-a15a-4e77-922c-24a5db2118bc2025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINENorthStar Rx LLC3e1e767b-66a5-4f38-8142-84d40d447f922025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limitedd0f00a25-1aec-42fd-a301-d3710ae3e1f32025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FLUOXETINEFLUOXETINEStrides Pharma Science Limitedca749349-d0e1-4b7c-b4c0-e392e72cf0f62025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FLUOXETINEFLUOXETINESaptalis Pharmaceuticals, LLC.4527c502-b28c-449f-ad2d-7daf21563cfa2025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBryant Ranch Prepackada19ae4-f3bd-47fa-a5c3-a6bb3aa349432025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack80816531-9db3-492b-aebc-4681bf3c15542025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackda785a8a-d897-494e-9fd2-1d09b32f01902025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEPD-Rx Pharmaceuticals, Inc.620ecf00-5473-4420-afd1-94b5b38e73012025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAmerican Health Packaging3276a2a4-61c7-4de6-b519-3aa8b62da88f2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Fluoxetine HydrochlorideFLUOXETINE HYDROCHLORIDELupin Pharmaceuticals, Inc.f274f102-67ec-46e7-b248-533be2e3003b2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAlembic Pharmaceuticals Inc.9de65da4-73f8-4c88-8198-c92e63224ddb2025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBryant Ranch Prepack7a631271-9597-42a4-a924-1d06ecaba8c82025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDERedpharm Drug0b3da881-475d-cdee-e063-6394a90aee992025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Fluoxetine HCLFLUOXETINE HCLDirect_Rx0259db51-e1ff-6e7a-e063-6394a90abace2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.a7ba9184-7dad-4f82-a947-bb2cc6b760ce2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FLUOXETINEFLUOXETINE HYDROCHLORIDEDIRECT RX9b8d8da5-8c06-0942-e053-2995a90aa2c92025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAdvanced Rx Pharmacy of Tennessee, LLCf917063a-226e-0978-e053-6294a90aeb4b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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