Celecoxib
- Product NDC
- 71610-584
- 11-digit product format
- 716100584
- Labeler code
- 71610
- Product ID
- 71610-584_b3ea8ff0-0539-46fc-9ab6-aa6e8cb72549
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA205129
- Marketing category
- ANDA
- Marketing start
- 2021-04-15
- 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 |
|---|
| 71610-584-30 | 71610058430 | 30 CAPSULE in 1 BOTTLE (71610-584-30) | 30 capsule | 2021-07-20 | No | No | Historical |
| 71610-584-53 | 71610058453 | 60 CAPSULE in 1 BOTTLE (71610-584-53) | 60 capsule | 2021-07-20 | No | No | Historical |
| 71610-584-60 | 71610058460 | 90 CAPSULE in 1 BOTTLE (71610-584-60) | 90 capsule | 2021-07-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Celecoxib | Aphena Pharma Solutions - Tennessee, LLC | 2021-08-09 | HUMAN PRESCRIPTION DRUG LABEL | 1 |