Celecoxib
- Product NDC
- 70518-4619
- 11-digit product format
- 705184619
- Labeler code
- 70518
- Product ID
- 70518-4619_503820df-7797-3dbc-e063-6294a90a1d24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205129
- Marketing category
- ANDA
- Marketing start
- 2026-04-24
- Substance
- CELECOXIB
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JCX84Q7J1L |
| Rxcui | 349514 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4619-0 | Celecoxib | 50 in 1 BOX | CAPSULE | 50 | | 1 |
| 70518-4619-1 | Celecoxib | 1 in 1 POUCH | CAPSULE | 1 | | 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 |
|---|
| 70518-4619-0 | 70518461900 | 50 POUCH in 1 BOX (70518-4619-0) / 1 CAPSULE in 1 POUCH (70518-4619-1) | 50 pouch | 2026-04-24 | No | No | Historical |
| 70518-4619-1 | 70518461901 | 1 in 1 POUCH | | | | | Historical |