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 6 of 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEPar Health USA, LLC6fff3732-efc3-4cbd-a8fa-cde3181f03e62024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.be4c5102-e0aa-3b89-e053-2a95a90a5d9d2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINETorrent Pharmaceuticals Limiteddcebc7cf-6f95-4f7a-a22b-c7d2e0f04d742024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions9a151528-2fe0-4059-b7b7-fcb4e80a51e32024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions42c4c341-8282-4961-8581-8a04301625592024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEProficient Rx LPcece294b-c414-4832-a8a2-22fb66aabda92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEProficient Rx LP5ebf287e-fc95-4a2c-a496-62c7cf6cbf382024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions2f302db0-1c88-44cf-8258-3c1c60afb5a42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepacke15646e0-a431-4b3d-8d6f-7a3d0dadfcc62024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack3d5d03ff-0d0c-429f-b747-31ff3465d39d2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions1226a67f-ec09-42f6-9d1b-9ddd862ea0a02024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.b1409772-e719-67f5-e053-2995a90ab5b62024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a32f1a0b-a9ee-883a-e053-2a95a90a8c122024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a7bea6e9-cf90-a963-e053-2a95a90a10682024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINENuCare Pharmaceuticals,Inc.5631bb72-798a-6efc-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINECadila Pharmaceuticals Limited9651816f-58f5-4bf8-8183-6f3d84d36b5c2024-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEModavar Pharmaceuticals LLC05b0781b-50e2-4311-bde0-430b96e2ef8e2024-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.50345702-9869-5335-e054-00144ff88e882024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDENorthStar Rx LLC1f8b1834-d5d7-72b6-d2ed-cb074344d59e2024-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINENuCare Pharmaceuticals,Inc.78994632-74b3-951c-e053-2a91aa0ac1c82024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ

Reported adverse events (FAERS/openFDA)#

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