Celecoxib
- Product NDC
- 83301-0028
- 11-digit product format
- 833010028
- Labeler code
- 83301
- Product ID
- 83301-0028_4d7d9800-75a8-5017-e063-6294a90ac45a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mullan Pharmaceutical Inc.
- Application
- ANDA210071
- Marketing category
- ANDA
- Marketing start
- 2024-01-01
- Substance
- CELECOXIB
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JCX84Q7J1L |
| Rxcui | 205322, 205323, 686379 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83301-0028-1 | Celecoxib | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83301-0028 | CELECOXIB CAPSULE [MULLAN PHARMACEUTICAL INC.] | 2 | Current NDC, 1 package rows | 20250425_643e177f-216d-4dfa-824a-7516a488304e.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 |
|---|
| 83301-0028-1 | 83301002801 | 60 CAPSULE in 1 BOTTLE (83301-0028-1) | 60 capsule | 2024-01-01 | No | No | Current |