Celecoxib
- Product NDC
- 45865-840
- 11-digit product format
- 458650840
- Labeler code
- 45865
- Product ID
- 45865-840_9ab47faa-a90e-a695-e053-2a95a90a270e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- NDA020998
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-12-10
- Marketing end
- 0000-00-00
- Substance
- CELECOXIB
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bff1fbab-f4cc-4993-b7de-2b555ee5eb73 | Product name | 1 | 20220509 |
| cc117a7e-1ef6-4866-90a7-ce0d190eef9a | Product name | 1 | 20200925 |
| 827beb42-45f2-95b8-6aa3-f35174375422 | Product name | 9 | 20160429 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45865-840-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-a749-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib Capsules Initial U.S. Approval: 1998 |
| 45865-840-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-a749-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib Capsules Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45865-840-30 | Celecoxib | 30 in 1 BOTTLE | CAPSULE | 30 | 2 | |
| 45865-840-60 | Celecoxib | 60 in 1 BOTTLE | CAPSULE | 60 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CELECOXIB | ACTIVE INGREDIENT | JCX84Q7J1L | CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CELECOXIB | ACTIVE MOIETY | JCX84Q7J1L | CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 205323 | celecoxib 200 MG Oral Capsule | PSN | 2087ead6-69b3-5f5a-e054-00144ff8d46c | 2 |
| 205323 | celecoxib 200 MG Oral Capsule | SCD | 2087ead6-69b3-5f5a-e054-00144ff8d46c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45865-840-30 | 45865084030 | 30 CAPSULE in 1 BOTTLE (45865-840-30) | 30 capsule | 2015-09-24 | 0000-00-00 | No | No | Current |
| 45865-840-60 | 45865084060 | 60 CAPSULE in 1 BOTTLE (45865-840-60) | 60 capsule | 2015-09-24 | 0000-00-00 | No | No | Current |