CELECOXIB

Product NDC
63187-301
11-digit product format
631870301
Labeler code
63187
Product ID
63187-301_2680eafe-f0cd-481e-830f-51b249135bdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207446
Marketing category
ANDA
Marketing start
2015-09-23
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
63187-301-306318703013030 CAPSULE in 1 BOTTLE (63187-301-30) 30 capsule2016-05-02NoNoHistorical
63187-301-606318703016060 CAPSULE in 1 BOTTLE (63187-301-60) 60 capsule2016-05-02NoNoHistorical
63187-301-906318703019090 CAPSULE in 1 BOTTLE (63187-301-90) 90 capsule2016-05-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CELECOXIBProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL3