CELEBREX

Product NDC
63187-079
11-digit product format
631870079
Labeler code
63187
Product ID
63187-079_df47793e-33f4-4823-b58f-ad991b48b22f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA020998
Marketing category
NDA
Marketing start
1998-10-02
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-079CELEBREX (CELECOXIB) CAPSULE [PROFICIENT RX LP]3Legacy NDC20210121_9f9dd7b9-a072-46d0-a8b5-b3e138c85f1c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-079-156318700791515 CAPSULE in 1 BOTTLE (63187-079-15) 15 capsule2019-01-010000-00-00NoNoCurrent