Celecoxib
- Product NDC
- 80425-0281
- 11-digit product format
- 804250281
- Labeler code
- 80425
- Product ID
- 80425-0281_2a9ba8f4-6cea-e827-e063-6394a90a0300
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA210628
- Marketing category
- ANDA
- Marketing start
- 2023-03-03
- Substance
- CELECOXIB
- Active strength
- 200 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 UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| JCX84Q7J1L | CELECOXIB | 169590-42-5 | CELECOXIB |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0281-1 | 80425028101 | 30 CAPSULE in 1 BOTTLE (80425-0281-1) | 30 capsule | 2023-03-03 | No | No | Historical |
| 80425-0281-2 | 80425028102 | 60 CAPSULE in 1 BOTTLE (80425-0281-2) | 60 capsule | 2023-03-03 | No | No | Historical |
| 80425-0281-3 | 80425028103 | 90 CAPSULE in 1 BOTTLE (80425-0281-3) | 90 capsule | 2023-03-03 | No | No | Historical |
| 80425-0281-4 | 80425028104 | 180 CAPSULE in 1 BOTTLE (80425-0281-4) | 180 capsule | 2023-03-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Celecoxib Capsules | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |