Celecoxib

Product NDC
63187-643
11-digit product format
631870643
Labeler code
63187
Product ID
63187-643_87d8cb44-f135-4660-8988-ad81480a9308
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200562
Marketing category
ANDA
Marketing start
2015-03-12
Substance
CELECOXIB
Active strength
100 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
JCX84Q7J1LCELECOXIB169590-42-5CELECOXIB

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63187-643-306318706433030 CAPSULE in 1 BOTTLE (63187-643-30) 30 capsule2018-12-01NoNoHistorical
63187-643-606318706436060 CAPSULE in 1 BOTTLE (63187-643-60) 60 capsule2018-12-01NoNoHistorical
63187-643-906318706439090 CAPSULE in 1 BOTTLE (63187-643-90) 90 capsule2018-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CelecoxibProficient Rx LP2023-12-01HUMAN PRESCRIPTION DRUG LABEL6