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 3 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCeca923da-59fa-da2e-e053-2a95a90a6a512026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBPreferred Pharmaceutical Inc.7f20976d-bed3-4a06-9aaf-f5b5240e4ce32026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepack47be1d99-eebb-42f9-80d9-291a024b13642026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAvet Pharmaceuticals Inc.4bc96d0c-b484-3cee-e063-6294a90a91932026-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBScieGen Pharmaceuticals, Inc.8709cbe7-3de1-4908-a0a9-53002bcee15b2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBDirect Rxac87b4f9-3f66-8cf7-e053-2995a90ade0f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBSportpharm LLC528a6f12-9878-4005-8fc2-5997adbb287f2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
celecoxibCELECOXIBSportpharm LLC1ae11faa-5bbe-49b7-a4dd-b573c304cf662026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBUmedica Laboratories USA Inc.b0e0243e-59b3-4f73-8c21-86b60fc7894b2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBQingdao BAHEAL Pharmaceutical Co., Ltd.87c16a33-5eb0-40b0-a020-ed924326f6972026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNIVAGEN PHARMACEUTICALS, INC.ae7943ab-b1fc-f08f-e053-2995a90a051e2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthwind Health Company, LLCf874eddf-b2f3-6830-e053-6394a90ade7a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthwind Health Company, LLCf2a0db9f-174b-1603-e053-2995a90a79a32026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
celecoxibCELECOXIBNorthwind Health Company, LLCc213e224-c2fb-726e-e053-2a95a90a21c52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthwind Health Company, LLCdabfb290-0a7f-3429-e053-2a95a90ae04c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthwind Health Company, LLCdac05189-4acf-d6bb-e053-2a95a90a46a92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBRedPharm Drug2fbaa580-f33a-417d-e063-6294a90ad7df2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBYiling Pharmaceutical, Inc.43979279-867b-4303-8f30-fc58ae75a0692025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBChartwell RX, LLCa99a67f3-ccaa-4d54-8922-d6dd30fba2742025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAlembic Pharmaceuticals Limited14e8d788-e44c-4a40-8678-25cf45fed4772025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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