CELEBREX

Product NDC
49999-383
11-digit product format
499990383
Labeler code
49999
Product ID
49999-383_836e2ffd-c264-4ca6-8882-c352941e53bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
NDA020998
Marketing category
NDA
Marketing start
2011-11-22
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
49999-383-10CELEBREX10 in 1 BOTTLECAPSULE103247
49999-383-30CELEBREX30 in 1 BOTTLECAPSULE303247
49999-383-60CELEBREX60 in 1 BOTTLECAPSULE603247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-383-10EA - Each49999-38366310b28-9728-4394-b725-0aa92e6540a212012-07-24
49999-383-30EA - Each49999-383a0469ef8-819b-4d31-ade1-df0bbad6b7a012012-07-24
49999-383-60EA - Each49999-38388212cb7-18af-4abc-b464-f87dbdc05b2c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-383CELEBREX (CELECOXIB) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3247Legacy NDC, 3 package rows20170320_2aea0f50-b823-42ba-ab13-b40168bd55a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213468CeleBREX 100 MG Oral CapsulePSN2aea0f50-b823-42ba-ab13-b40168bd55a23247
205322celecoxib 100 MG Oral CapsulePSN2aea0f50-b823-42ba-ab13-b40168bd55a23247
213468celecoxib 100 MG Oral Capsule [Celebrex]SBD2aea0f50-b823-42ba-ab13-b40168bd55a23247
205322celecoxib 100 MG Oral CapsuleSCD2aea0f50-b823-42ba-ab13-b40168bd55a23247
213468Celebrex 100 MG Oral CapsuleSY2aea0f50-b823-42ba-ab13-b40168bd55a23247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49999-383-104999903831010 in 1 BOTTLEHistorical
49999-383-304999903833030 in 1 BOTTLEHistorical
49999-383-604999903836060 in 1 BOTTLEHistorical