Celecoxib
- Product NDC
- 68788-8197
- 11-digit product format
- 687888197
- Labeler code
- 68788
- Product ID
- 68788-8197_b3a05107-8958-4473-8607-396a2c90081b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA205129
- Marketing category
- ANDA
- Marketing start
- 2022-05-23
- 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
- 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 | 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 |
|---|
| 68788-8197-1 | Celecoxib | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 68788-8197-3 | Celecoxib | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
| 68788-8197-6 | Celecoxib | 60 in 1 BOTTLE | CAPSULE | 60 | | 5 |
| 68788-8197-8 | Celecoxib | 120 in 1 BOTTLE | CAPSULE | 120 | | 5 |
| 68788-8197-9 | Celecoxib | 90 in 1 BOTTLE | CAPSULE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8197 | CELECOXIB CAPSULE [PREFERRED PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20250221_f2a5ffbd-49c4-4a97-867b-2b14a3675020.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8197-1 | 68788819701 | 100 CAPSULE in 1 BOTTLE (68788-8197-1) | 100 capsule | 2022-05-23 | 0000-00-00 | No | No | Current |
| 68788-8197-3 | 68788819703 | 30 CAPSULE in 1 BOTTLE (68788-8197-3) | 30 capsule | 2022-05-23 | 0000-00-00 | No | No | Current |
| 68788-8197-6 | 68788819706 | 60 CAPSULE in 1 BOTTLE (68788-8197-6) | 60 capsule | 2022-05-23 | 0000-00-00 | No | No | Current |
| 68788-8197-8 | 68788819708 | 120 CAPSULE in 1 BOTTLE (68788-8197-8) | 120 capsule | 2022-05-23 | 0000-00-00 | No | No | Current |
| 68788-8197-9 | 68788819709 | 90 CAPSULE in 1 BOTTLE (68788-8197-9) | 90 capsule | 2022-05-23 | 0000-00-00 | No | No | Current |