FDA.reportPublic FDA data

Celecoxib

Product NDC
70518-3733
11-digit product format
705183733
Labeler code
70518
Product ID
70518-3733_4f8151c4-c071-73a0-e063-6394a90a4696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205129
Marketing category
ANDA
Marketing start
2023-05-22
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
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
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
70518-3733-0Celecoxib45 in 1 BOTTLE, PLASTICCAPSULE458
70518-3733-1Celecoxib30 in 1 BOTTLE, PLASTICCAPSULE308
70518-3733-2Celecoxib90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3733-3Celecoxib60 in 1 BOTTLE, PLASTICCAPSULE608
70518-3733-4Celecoxib14 in 1 BOTTLE, PLASTICCAPSULE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3733-1EA - Each70518-373356e63060-7338-47f9-bd29-a062f713650d12026-02-05
70518-3733-2EA - Each70518-37338e02b8d2-99d2-407c-919d-340c5dc16ec312026-02-05
70518-3733-3EA - Each70518-3733c73c1587-0319-41ae-9815-1746b29be13512026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3733CELECOXIB CAPSULE [REMEDYREPACK INC.]6Current NDC, 5 package rows20241127_b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNb3acbfd9-a1c2-4aa6-b5f0-013cfad6cca88
205323celecoxib 200 MG Oral CapsuleSCDb3acbfd9-a1c2-4aa6-b5f0-013cfad6cca88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3733-07051837330045 in 1 BOTTLE, PLASTICHistorical
70518-3733-17051837330130 CAPSULE in 1 BOTTLE, PLASTIC (70518-3733-1) 30 capsule2023-05-24NoNoHistorical
70518-3733-27051837330290 CAPSULE in 1 BOTTLE, PLASTIC (70518-3733-2) 90 capsule2023-07-10NoNoHistorical
70518-3733-37051837330360 in 1 BOTTLE, PLASTICHistorical
70518-3733-47051837330414 in 1 BOTTLE, PLASTICHistorical