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 7 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
celecoxibCELECOXIBA-S Medication Solutions85bfe02b-bfcb-44ee-81a0-11765c3054a92023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
celecoxibCELECOXIBProficient Rx LP0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d02022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
celecoxibCELECOXIBProficient Rx LPcbd2d6de-6f0d-4b69-8e27-a1fe08830ba52022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBTianjin Tianyao Pharmaceuticals Co., Ltd.76f9bcb7-0e94-485f-816d-61d4e1ed24e02022-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBAphena Pharma Solutions - Tennessee, LLCd258e065-e9a6-44e2-89c9-6892d771d9d32021-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBProficient Rx LPc91e5933-1798-4096-9f08-fb1200e154e12021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LP6dd743d3-4821-4919-90eb-6d306ca7999f2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
a864ef99-fd9f-2b3d-2cb1-dd6f44f6af8234454fef-e029-513c-f843-21f5cd3362ab2020-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: a864ef99-fd9f-2b3d-2cb1-dd6f44f6af82
spl set id: 34454fef-e029-513c-f843-21f5cd3362ab
Celecoxib 200 mgCELECOXIBProficient Rx LPfeee6a01-63f9-42c3-8bd8-ca713a08b36d2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LP7a234c0c-30a7-49f5-92a1-a1fc836ff9ae2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LPc787b0ab-77ab-4f7e-9fea-be2a0085020a2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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