Celecoxib
- Product NDC
- 50436-7901
- 11-digit product format
- 504367901
- Labeler code
- 50436
- Product ID
- 50436-7901_4eb0c01b-f375-4c01-b53e-84c78cf319c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- NDA020998
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-12-10
- Marketing end
- 0000-00-00
- Substance
- CELECOXIB
- Active strength
- 100 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 |
|---|---|---|---|---|---|
| 50436-7901-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-186e-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib capsules, for oral use Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-7901-1 | Celecoxib | 30 in 1 BOTTLE | CAPSULE | 30 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-7901-1 | EA - Each | 50436-7901 | f69e9405-8bba-44fa-9b06-8f16e5c1101f | 1 | 2016-05-16 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CELECOXIB | ACTIVE INGREDIENT | JCX84Q7J1L | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 2 | |
| CELECOXIB | ACTIVE MOIETY | JCX84Q7J1L | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-7901 | CELECOXIB CAPSULE [UNIT DOSE SERVICES] | 8 | Legacy NDC, 1 package rows | 20170702_fbe2ac60-fc15-471a-b616-7a378a549f1c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 205322 | celecoxib 100 MG Oral Capsule | PSN | fbe2ac60-fc15-471a-b616-7a378a549f1c | 8 |
| 205323 | celecoxib 200 MG Oral Capsule | PSN | fbe2ac60-fc15-471a-b616-7a378a549f1c | 8 |
| 205322 | celecoxib 100 MG Oral Capsule | SCD | fbe2ac60-fc15-471a-b616-7a378a549f1c | 8 |
| 205323 | celecoxib 200 MG Oral Capsule | SCD | fbe2ac60-fc15-471a-b616-7a378a549f1c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-7901-1 | 50436790101 | 30 in 1 BOTTLE | Historical |