FDA.reportPublic FDA data

CELECOXIB

Product NDC
70518-3424
11-digit product format
705183424
Labeler code
70518
Product ID
70518-3424_4f07e77f-f0d2-196a-e063-6294a90afb5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210628
Marketing category
ANDA
Marketing start
2022-05-25
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CELECOXIB
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3424-0CELECOXIB30 in 1 BOTTLE, PLASTICCAPSULE307
70518-3424-1CELECOXIB60 in 1 BOTTLE, PLASTICCAPSULE607
70518-3424-2CELECOXIB90 in 1 BOTTLE, PLASTICCAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3424CELECOXIB CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250525_d0ca85fa-8b80-4a48-a1a4-a1c181821c39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNd0ca85fa-8b80-4a48-a1a4-a1c181821c397
205322celecoxib 100 MG Oral CapsuleSCDd0ca85fa-8b80-4a48-a1a4-a1c181821c397

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3424-07051834240030 CAPSULE in 1 BOTTLE, PLASTIC (70518-3424-0) 30 capsule2022-05-250000-00-00NoNoCurrent
70518-3424-17051834240160 CAPSULE in 1 BOTTLE, PLASTIC (70518-3424-1) 60 capsule2025-05-23NoNoCurrent
70518-3424-27051834240290 CAPSULE in 1 BOTTLE, PLASTIC (70518-3424-2) 90 capsule2025-06-16NoNoCurrent