Celecoxib
- Product NDC
- 0591-3983
- 11-digit product format
- 005913983
- Labeler code
- 0591
- Product ID
- 0591-3983_42c5f4e4-5a65-4062-bf0a-b640659bc6f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA200562
- Marketing category
- ANDA
- Marketing start
- 2015-03-12
- Marketing end
- 2026-09-30
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Celecoxib
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 |
|---|
| 0591-3983-01 | Celecoxib | 100 in 1 BOTTLE | CAPSULE | 100 | | 21 |
| 0591-3983-05 | Celecoxib | 500 in 1 BOTTLE | CAPSULE | 500 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CELECOXIB | ACTIVE INGREDIENT | JCX84Q7J1L | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 5 | |
| CELECOXIB | ACTIVE MOIETY | JCX84Q7J1L | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-3983 | CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20250411_05224473-27dc-4f6d-a52a-c40a7af2f2f4.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 |
|---|
| 0591-3983-01 | 00591398301 | 100 CAPSULE in 1 BOTTLE (0591-3983-01) | 100 capsule | 2015-03-12 | 2026-09-30 | No | No | Current |
| 0591-3983-05 | 00591398305 | 500 CAPSULE in 1 BOTTLE (0591-3983-05) | 500 capsule | 2015-03-12 | 2026-09-30 | No | No | Current |