Celecoxib

Product NDC
70518-4175
11-digit product format
705184175
Labeler code
70518
Product ID
70518-4175_3fba03bc-9533-2d54-e063-6394a90a8571
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210071
Marketing category
ANDA
Marketing start
2024-09-16
Substance
CELECOXIB
Active strength
200 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205323

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
70518-4175-0Celecoxib14 in 1 BOTTLE, PLASTICCAPSULE146
70518-4175-1Celecoxib60 in 1 BOTTLE, PLASTICCAPSULE606
70518-4175-2Celecoxib90 in 1 BOTTLE, PLASTICCAPSULE906
70518-4175-3Celecoxib30 in 1 BOTTLE, PLASTICCAPSULE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4175CELECOXIB CAPSULE [REMEDYREPACK INC.]5Current NDC, 4 package rows20250508_c96509cc-47f4-44f8-9f7e-4e49cc3d5348.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNc96509cc-47f4-44f8-9f7e-4e49cc3d53486
205323celecoxib 200 MG Oral CapsuleSCDc96509cc-47f4-44f8-9f7e-4e49cc3d53486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4175-07051841750014 CAPSULE in 1 BOTTLE, PLASTIC (70518-4175-0) 14 capsule2024-09-16NoNoHistorical
70518-4175-17051841750160 CAPSULE in 1 BOTTLE, PLASTIC (70518-4175-1) 60 capsule2024-09-18NoNoHistorical
70518-4175-27051841750290 CAPSULE in 1 BOTTLE, PLASTIC (70518-4175-2) 90 capsule2025-04-29NoNoHistorical
70518-4175-37051841750330 CAPSULE in 1 BOTTLE, PLASTIC (70518-4175-3) 30 capsule2025-05-06NoNoHistorical