INDOMETHACIN
- Product NDC
- 68382-470
- 11-digit product format
- 683820470
- Labeler code
- 68382
- Product ID
- 68382-470_37cff808-1732-462d-857b-6173382e5cba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- INDOMETHACIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA206561
- Marketing category
- ANDA
- Marketing start
- 2021-05-15
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN SODIUM
- Active strength
- 1 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
- 2023-12-31
- 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 |
|---|
| 68382-470-01 | 68382047001 | 1 VIAL in 1 CARTON (68382-470-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2021-05-15 | 0000-00-00 | No | No | Current |