Celecoxib 200 mg

Product NDC
69399-194
11-digit product format
693990194
Labeler code
69399
Product ID
69399-194_cf5aa65e-7b73-495d-9115-efd878f259c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
SYDON LABS LLC
Application
ANDA204519
Marketing category
ANDA
Marketing start
2017-03-17
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
69399-194-81Celecoxib 200 mg100 in 1 BOTTLECAPSULE1001
69399-194-85Celecoxib 200 mg500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69399-194-85EA - Each69399-19436962c82-27e7-4a32-b0e5-5a84898dce8812017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69399-194CELECOXIB 200 MG (CELECOXIB) CAPSULE [SYDON LABS LLC]1Legacy NDC, 2 package rows20170323_31b74a7a-50eb-48a5-8285-05bb5df8fbd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN31b74a7a-50eb-48a5-8285-05bb5df8fbd81
205323celecoxib 200 MG Oral CapsuleSCD31b74a7a-50eb-48a5-8285-05bb5df8fbd81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69399-194-8169399019481100 in 1 BOTTLEHistorical
69399-194-8569399019485500 in 1 BOTTLEHistorical