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 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBMajor Pharmaceuticals3a1eadd5-c0a7-473e-bde0-6b9450d11c952026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.c96509cc-47f4-44f8-9f7e-4e49cc3d53482026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBDirectRxe0f3aacf-df5d-dad7-e053-2995a90ac5eb2026-08-27Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBA-S Medication Solutionse84d67c8-010d-495c-8691-ae16d0698f8d2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy59f495e8-3cea-9d98-e063-6394a90a89d42026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBMullan Pharmaceutical Inc.643e177f-216d-4dfa-824a-7516a488304e2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca82026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.e18d2fa4-4982-4e2a-af55-4319d6416efb2026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBA-S Medication Solutionsd799328f-9ea0-4b64-9667-8feaa97f150c2026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.b06ced10-81c6-4f48-a205-1e0db228cb8b2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAlembic Pharmaceuticals Inc.806e5f8a-f986-4f88-ba3e-8265f86afa482026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBREMEDYREPACK INC.27f17ae7-939b-402e-9498-3b66111040892026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.06076494-62ad-4f58-b8bb-7038fcfe3b122026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy3bc74e76-0517-69c6-e063-6394a90abe752026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBCardinal Health 107, LLCa9114d6a-13d7-443c-be44-7866b4a4cf962026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
celecoxibCELECOXIBHAWAII REPACK, INC.45816eae-ad83-4d2f-a035-c3f9f24708f92026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBHAWAII REPACK, INC.77f3b90b-a25d-4c47-975a-2a988d696a3f2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBSt Mary's Medical Park Pharmacye1ab644d-b668-3cf3-e053-2995a90addb02026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBRadha Pharmaceuticals, Inc.2c86ece8-1cf5-4688-91b1-8aef5d60b7e42026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBBryant Ranch Prepackd94849a7-1831-4319-982c-c6b20dc420382026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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