Celecoxib
- Product NDC
- 10544-953
- 11-digit product format
- 105440953
- Labeler code
- 10544
- Product ID
- 10544-953_31028c97-a033-6635-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA204197
- Marketing category
- ANDA
- Marketing start
- 2015-11-05
- Marketing end
- 0000-00-00
- Substance
- CELECOXIB
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-953-14 | Celecoxib | 14 in 1 BOTTLE | CAPSULE | 14 | | 2 |
| 10544-953-30 | Celecoxib | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CELECOXIB | ACTIVE INGREDIENT | JCX84Q7J1L | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELECOXIB | ACTIVE MOIETY | JCX84Q7J1L | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-953 | CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 2 package rows | 20160421_23e5c271-3d06-5a63-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-953-14 | 10544095314 | 14 in 1 BOTTLE | Historical |
| 10544-953-30 | 10544095330 | 30 in 1 BOTTLE | Historical |