Indomethacin
- Product NDC
- 51655-443
- 11-digit product format
- 516550443
- Labeler code
- 51655
- Product ID
- 51655-443_4b444cf9-9cbb-c2aa-e063-6394a90a0512
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA201807
- Marketing category
- ANDA
- Marketing start
- 2020-09-30
- Substance
- INDOMETHACIN
- Active strength
- 75 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
- 2027-12-31
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-443-52 | 51655044352 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-443-52) | 2020-09-30 | No | No | Historical |
| 51655-443-84 | 51655044384 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-443-84) | 2020-09-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Indomethacin | Northwind Health Company, LLC | 2026-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 4 |