Indomethacin
- Product NDC
- 71205-822
- 11-digit product format
- 712050822
- Labeler code
- 71205
- Product ID
- 71205-822_0193c0a4-f595-609c-e063-6294a90aaa68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201807
- Marketing category
- ANDA
- Marketing start
- 2015-07-24
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Indomethacin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INDOMETHACIN | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 310992 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-822-30 | Indomethacin | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 2 |
| 71205-822-60 | Indomethacin | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 2 |
| 71205-822-90 | Indomethacin | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-822 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP] | 2 | Current NDC, 3 package rows | 20230729_ac458b4b-95bb-4235-a447-e8c4ba720257.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-822-30 | 71205082230 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-30) | 2023-07-26 | No | No | Current |
| 71205-822-60 | 71205082260 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-60) | 2023-07-26 | No | No | Current |
| 71205-822-90 | 71205082290 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-90) | 2023-07-26 | No | No | Current |