Celecoxib

Product NDC
70518-3826
11-digit product format
705183826
Labeler code
70518
Product ID
70518-3826_3f686042-02c3-8a78-e063-6294a90a7f56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210071
Marketing category
ANDA
Marketing start
2023-08-12
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
70518-3826-07051838260090 CAPSULE in 1 BOTTLE, PLASTIC (70518-3826-0) 90 capsule2023-08-12NoNoHistorical
70518-3826-27051838260260 CAPSULE in 1 BOTTLE, PLASTIC (70518-3826-2) 60 capsule2025-04-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CelecoxibREMEDYREPACK INC.2025-09-22HUMAN PRESCRIPTION DRUG LABEL5