Indomethacin extended-release
- Product NDC
- 59746-379
- 11-digit product format
- 597460379
- Labeler code
- 59746
- Product ID
- 59746-379_c026ff62-b30d-4637-88af-8b67914711f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin extended-release
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmaceuticals Inc.
- Application
- ANDA202706
- Marketing category
- ANDA
- Marketing start
- 2015-10-05
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 75 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59746-379-01 | 59746037901 | 100 CAPSULE in 1 BOTTLE (59746-379-01) | 100 capsule | 2015-10-05 | 0000-00-00 | No | No | Current |
| 59746-379-05 | 59746037905 | 500 CAPSULE in 1 BOTTLE (59746-379-05) | 500 capsule | 2015-10-05 | 0000-00-00 | No | No | Current |
| 59746-379-60 | 59746037960 | 60 CAPSULE in 1 BOTTLE (59746-379-60) | 60 capsule | 2015-10-05 | 0000-00-00 | No | No | Current |
| 59746-379-90 | 59746037990 | 90 CAPSULE in 1 BOTTLE (59746-379-90) | 90 capsule | 2015-10-05 | 0000-00-00 | No | No | Current |