Celecoxib
- Product NDC
- 85509-1158
- 11-digit product format
- 855091158
- Labeler code
- 85509
- Product ID
- 85509-1158_3a7b11a9-f0cd-d0d9-e063-6294a90a1b85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA205129
- Marketing category
- ANDA
- Marketing start
- 2020-12-03
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Celecoxib
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CELECOXIB | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JCX84Q7J1L |
| Rxcui | 205323 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85509-1158-1 | Celecoxib | 10 in 1 BOTTLE | CAPSULE | 10 | | 1 |
| 85509-1158-3 | Celecoxib | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 85509-1158-6 | Celecoxib | 60 in 1 BOTTLE | CAPSULE | 60 | | 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 |
|---|
| 85509-1158-1 | 85509115801 | 10 CAPSULE in 1 BOTTLE (85509-1158-1) | 10 capsule | 2025-07-31 | No | No | Historical |
| 85509-1158-3 | 85509115803 | 30 CAPSULE in 1 BOTTLE (85509-1158-3) | 30 capsule | 2025-07-31 | No | No | Historical |
| 85509-1158-6 | 85509115806 | 60 CAPSULE in 1 BOTTLE (85509-1158-6) | 60 capsule | 2025-07-31 | No | No | Historical |