CELEBREX
- Product NDC
- 58151-083
- 11-digit product format
- 581510083
- Labeler code
- 58151
- Product ID
- 58151-083_0c321a7b-89e4-48cc-ab0b-1bd7620d7799
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA020998
- Marketing category
- NDA
- Marketing start
- 2024-09-13
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CELEBREX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CELECOXIB | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JCX84Q7J1L |
| Rxcui | 205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58151-083-01 | CELEBREX | 100 in 1 BOTTLE | CAPSULE | 100 | | 13 |
| 58151-083-05 | CELEBREX | 500 in 1 BOTTLE | CAPSULE | 500 | | 13 |
| 58151-083-32 | CELEBREX | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 13 |
| 58151-083-88 | CELEBREX | 100 in 1 CARTON | CAPSULE | 100 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58151-083 | CELEBREX (CELECOXIB) CAPSULE [VIATRIS SPECIALTY LLC] | 12 | Current NDC, 4 package rows | 20250210_2d6675e4-5859-4be2-8037-a20ce9f707aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58151-083-01 | 58151008301 | 100 CAPSULE in 1 BOTTLE (58151-083-01) | 100 capsule | 2024-09-13 | No | No | Historical |
| 58151-083-05 | 58151008305 | 500 CAPSULE in 1 BOTTLE (58151-083-05) | 500 capsule | 2024-09-13 | No | No | Historical |
| 58151-083-32 | 58151008332 | 1 in 1 BLISTER PACK | | | | | Historical |
| 58151-083-88 | 58151008388 | 100 BLISTER PACK in 1 CARTON (58151-083-88) / 1 CAPSULE in 1 BLISTER PACK (58151-083-32) | 100 blister pack | 2024-09-17 | No | No | Historical |