celecoxib
- Product NDC
- 76420-243
- 11-digit product format
- 764200243
- Labeler code
- 76420
- Product ID
- 76420-243_31554477-2944-6b1d-e063-6294a90a3a9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA204590
- Marketing category
- ANDA
- Marketing start
- 2016-03-16
- 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
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| JCX84Q7J1L | CELECOXIB | 169590-42-5 | CELECOXIB |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-243-01 | 76420024301 | 1 CAPSULE in 1 BOTTLE (76420-243-01) | 1 capsule | 2022-07-27 | No | No | Historical |
| 76420-243-07 | 76420024307 | 7 CAPSULE in 1 BOTTLE (76420-243-07) | 7 capsule | 2022-07-27 | No | No | Historical |
| 76420-243-20 | 76420024320 | 20 CAPSULE in 1 BOTTLE (76420-243-20) | 20 capsule | 2024-01-09 | No | No | Historical |
| 76420-243-30 | 76420024330 | 30 CAPSULE in 1 BOTTLE (76420-243-30) | 30 capsule | 2022-07-27 | No | No | Historical |
| 76420-243-60 | 76420024360 | 60 CAPSULE in 1 BOTTLE (76420-243-60) | 60 capsule | 2022-07-27 | No | No | Historical |
| 76420-243-90 | 76420024390 | 90 CAPSULE in 1 BOTTLE (76420-243-90) | 90 capsule | 2022-07-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| celecoxib | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-03-27 | HUMAN PRESCRIPTION DRUG LABEL | 3 |