FDA.reportPublic FDA data

NDC 43598-866-04 - ELYXYB

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
43598-866
Requested NDC
43598-866-04
Package NDCs from labels
43598-866-04, 43598-866-09
Manufacturer
Dr. Reddy’s Laboratories, Inc | Dr. Reddy's Laboratories, Ltd.
Effective date
2020-05-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ELYXYB - Dr. Reddy’s Laboratories, Inc | Dr. Reddy's Laboratories, Ltd.Dr. Reddy’s Laboratories, Inc | Dr. Reddy's Laboratories, Ltd.2020-05-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-866-092022-01-28C16284748780-1d6a99b39-a616-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ELYXYB safely and effectively. See full prescribing information for ELYXYB. ELYXYB (celecoxib) oral solution Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-866-04ELYXYB4.8 mL in 1 BOTTLE, UNIT-DOSESOLUTION4.81
43598-866-09ELYXYB9 in 1 CARTONSOLUTION91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-866ELYXYB (CELECOXIB) SOLUTION [DR. REDDY’S LABORATORIES, INC]1Legacy NDC, 2 package rows20201005_34454fef-e029-513c-f843-21f5cd3362ab.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 2 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
celecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.78d59905-4a78-4d9f-ac29-58790a5b3a922026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepackfd569104-8243-48fa-8e93-5a08654ad6dd2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBRedpharm Drug5250529a-6a03-78a1-e063-6294a90a47f92026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.52572bfb-43f0-4b55-b1fd-231a05c8b83e2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAvPAK951df0f7-5fb7-40f5-e053-2995a90a1edd2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
celecoxibCELECOXIBMacleods Pharmaceuticals Limitedd14aecf5-16e9-459a-bda4-4ca8f290796a2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.56d64558-1fad-420e-8fcd-7103cd0731272026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBST. MARY'S MEDICAL PARK PHARMACYed2093f6-1606-100a-e053-2995a90a5b952026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.56127f57-7810-4f5d-a11d-e08fb2ed138b2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBApotex Corp.a62612b3-9564-2b34-be59-6aa5ac53679c2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBDirect_Rx4b2ffbdb-1847-d93b-e063-6394a90a06f52026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBNorthwind Health Company, LLC0de7a6f8-baba-1fd0-e063-6394a90ad4342026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBREMEDYREPACK INC.d0ca85fa-8b80-4a48-a1a4-a1c181821c392026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBST. MARY'S MEDICAL PARK PHARMACY4e57bd99-5b7a-c2c7-e063-6294a90afb8c2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAiPing Pharmaceutical, Inc.89db0dec-3800-4d89-a765-24838f4d0c302026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBPreferred Pharmaceuticals Inc.b0839895-6a36-4e4f-9336-98632b60622a2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBPreferred Pharmaceuticals, Inc.f2a5ffbd-49c4-4a97-867b-2b14a36750202026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
celecoxibCELECOXIBPreferred Pharmaceuticals Inc.a6000132-ac6c-4b61-a98a-8cc2dd84b3f02026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBPreferred Pharmaceuticals, Inc.d35d9494-4190-41a8-80d4-c9d877c432e92026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
celecoxibCELECOXIBPreferred Pharmaceuticals, Inc.2fc74af6-4573-411d-9082-f3edd44a52a42026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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