Celecoxib
- Product NDC
- 83008-075
- 11-digit product format
- 830080075
- Labeler code
- 83008
- Product ID
- 83008-075_a556a447-0f7f-4c37-a3ec-87dfa75618b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA205129
- Marketing category
- ANDA
- Marketing start
- 2024-07-24
- Marketing end
- 2026-05-31
- 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
- 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 83008-075-60 | 83008007560 | 60 CAPSULE in 1 BOTTLE (83008-075-60) | 60 capsule | 2024-07-24 | 2026-05-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Celecoxib | Quality Care Products, LLC | 2024-12-19 | HUMAN PRESCRIPTION DRUG LABEL | 4 |