Indomethacin
- Product NDC
- 76420-148
- 11-digit product format
- 764200148
- Labeler code
- 76420
- Product ID
- 76420-148_e49badcf-439d-5511-e053-2995a90a14bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA091240
- Marketing category
- ANDA
- Marketing start
- 2016-05-19
- Substance
- INDOMETHACIN
- Active strength
- 25 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
- 2026-12-31
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-148-14 | 76420014814 | 14 CAPSULE in 1 BOTTLE (76420-148-14) | 14 capsule | 2022-07-25 | No | No | Historical |
| 76420-148-20 | 76420014820 | 20 CAPSULE in 1 BOTTLE (76420-148-20) | 20 capsule | 2022-07-25 | No | No | Historical |
| 76420-148-30 | 76420014830 | 30 CAPSULE in 1 BOTTLE (76420-148-30) | 30 capsule | 2022-07-25 | No | No | Historical |
| 76420-148-60 | 76420014860 | 60 CAPSULE in 1 BOTTLE (76420-148-60) | 60 capsule | 2022-07-25 | No | No | Historical |
| 76420-148-90 | 76420014890 | 90 CAPSULE in 1 BOTTLE (76420-148-90) | 90 capsule | 2022-07-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Indomethacin | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2022-07-25 | HUMAN PRESCRIPTION DRUG LABEL | 1 |