Indomethacin extended-release
- Product NDC
- 71335-0137
- 11-digit product format
- 713350137
- Labeler code
- 71335
- Product ID
- 71335-0137_3e51d610-e593-45e4-8776-b00340f05e7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin extended-release
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 71335-0137-1 | 71335013701 | 30 CAPSULE in 1 BOTTLE (71335-0137-1) | 30 capsule | 2017-08-08 | 0000-00-00 | No | No | Current |
| 71335-0137-2 | 71335013702 | 60 CAPSULE in 1 BOTTLE (71335-0137-2) | 60 capsule | 2017-08-08 | 0000-00-00 | No | No | Current |
| 71335-0137-3 | 71335013703 | 14 CAPSULE in 1 BOTTLE (71335-0137-3) | 14 capsule | 2017-08-08 | 0000-00-00 | No | No | Current |
| 71335-0137-4 | 71335013704 | 10 CAPSULE in 1 BOTTLE (71335-0137-4) | 10 capsule | 2017-08-08 | 0000-00-00 | No | No | Current |
| 71335-0137-5 | 71335013705 | 7 CAPSULE in 1 BOTTLE (71335-0137-5) | 7 capsule | 2017-08-08 | 0000-00-00 | No | No | Current |
| 71335-0137-6 | 71335013706 | 15 CAPSULE in 1 BOTTLE (71335-0137-6) | 15 capsule | 2017-08-08 | 0000-00-00 | No | No | Current |
| 71335-0137-7 | 71335013707 | 20 CAPSULE in 1 BOTTLE (71335-0137-7) | 20 capsule | 2017-08-08 | 0000-00-00 | No | No | Current |
| 71335-0137-8 | 71335013708 | 90 CAPSULE in 1 BOTTLE (71335-0137-8) | 90 capsule | 2017-08-08 | 0000-00-00 | No | No | Current |