Celecoxib
- Product NDC
- 0904-7550
- 11-digit product format
- 009047550
- Labeler code
- 0904
- Product ID
- 0904-7550_3a1eadd5-c0a7-473e-bde0-6b9450d11c95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA204519
- Marketing category
- ANDA
- Marketing start
- 2026-04-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Celecoxib
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CELECOXIB | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JCX84Q7J1L |
| Rxcui | 205322, 205323 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7550-61 | Celecoxib | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 1 |
| 0904-7550-61 | Celecoxib | 100 in 1 CARTON | CAPSULE | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7550-61 | 00904755061 | 100 BLISTER PACK in 1 CARTON (0904-7550-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2026-04-06 | No | No | Historical |