Indomethacin
- Product NDC
- 53002-3500
- 11-digit product format
- 530023500
- Labeler code
- 53002
- Product ID
- 53002-3500_894c9586-d0f9-4a4d-8df4-483e90113203
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA091276
- Marketing category
- ANDA
- Marketing start
- 2010-12-22
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 50 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-3500-2 | 53002350002 | 20 CAPSULE in 1 BOTTLE (53002-3500-2) | 20 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-3500-3 | 53002350003 | 30 CAPSULE in 1 BOTTLE (53002-3500-3) | 30 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Indomethacin | RPK Pharmaceuticals, Inc. | 2023-06-07 | HUMAN PRESCRIPTION DRUG LABEL | 5 |