ELYXYB

Product NDC
43598-866
11-digit product format
435980866
Labeler code
43598
Product ID
43598-866_a864ef99-fd9f-2b3d-2cb1-dd6f44f6af82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
SOLUTION
Route
ORAL
Labeler
Dr. Reddy
Application
NDA212157
Marketing category
NDA
Marketing start
2020-10-05
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
25 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

FDA-Initiated Inactive NDC Indexing#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2373454celecoxib 120 MG in 4.8 mL Oral SolutionPSN34454fef-e029-513c-f843-21f5cd3362ab1
2373460Elyxyb 120 MG in 4.8 mL Oral SolutionPSN34454fef-e029-513c-f843-21f5cd3362ab1
2373460celecoxib 25 MG/ML Oral Solution [Elyxyb]SBD34454fef-e029-513c-f843-21f5cd3362ab1
2373454celecoxib 25 MG/ML Oral SolutionSCD34454fef-e029-513c-f843-21f5cd3362ab1
2373460Elyxyb 120 MG per 4.8 mL Oral SolutionSY34454fef-e029-513c-f843-21f5cd3362ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-866-04435980866044.8 mL in 1 BOTTLE, UNIT-DOSE4.8 mlHistorical
43598-866-09435980866099 BOTTLE, UNIT-DOSE in 1 CARTON (43598-866-09) > 4.8 mL in 1 BOTTLE, UNIT-DOSE (43598-866-04) 2020-10-050000-00-00NoNoCurrent