Celecoxib
- Product NDC
- 57582-212
- 11-digit product format
- 575820212
- Labeler code
- 57582
- Product ID
- 57582-212_30949e07-504d-43c2-b0d1-1c26dcaed176
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Tianjin Tianyao Pharmaceuticals Co., Ltd.
- Application
- ANDA207872
- Marketing category
- ANDA
- Marketing start
- 2020-02-25
- 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
- Celecoxib
- 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, 349514, 686379 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57582-212-01 | Celecoxib | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 57582-212-02 | Celecoxib | 500 in 1 BOTTLE | CAPSULE | 500 | | 5 |
| 57582-212-03 | Celecoxib | 100 in 1 CARTON | CAPSULE | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57582-212 | CELECOXIB (CELECOXIB) CAPSULE [TIANJIN TIANYAO PHARMACEUTICALS CO., LTD.
] | 5 | Current NDC, Legacy NDC, 3 package rows | 20220706_76f9bcb7-0e94-485f-816d-61d4e1ed24e0.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 |
|---|
| 57582-212-01 | 57582021201 | 100 CAPSULE in 1 BOTTLE (57582-212-01) | 100 capsule | 2020-02-25 | 0000-00-00 | No | No | Current |
| 57582-212-02 | 57582021202 | 500 CAPSULE in 1 BOTTLE (57582-212-02) | 500 capsule | 2020-02-25 | 0000-00-00 | No | No | Current |
| 57582-212-03 | 57582021203 | 100 CAPSULE in 1 CARTON (57582-212-03) | 100 capsule | 2020-02-25 | 0000-00-00 | No | No | Current |