Indomethacin
- Product NDC
- 68788-4055
- 11-digit product format
- 687884055
- Labeler code
- 68788
- Product ID
- 68788-4055_971c4d53-7876-4f42-ba2d-c391714fa341
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA091240
- Marketing category
- ANDA
- Marketing start
- 2025-11-17
- Substance
- INDOMETHACIN
- Active strength
- 50 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 |
|---|
| XXE1CET956 | INDOMETHACIN | 53-86-1 | INDOMETHACIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4055-3 | 68788405503 | 30 CAPSULE in 1 BOTTLE (68788-4055-3) | 30 capsule | 2025-11-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Indomethacin | Preferred Pharmaceuticals Inc. | 2025-11-17 | HUMAN PRESCRIPTION DRUG LABEL | 1 |