Indomethacin
- Product NDC
- 72865-148
- 11-digit product format
- 728650148
- Labeler code
- 72865
- Product ID
- 72865-148_f26f7451-69b2-99d7-e053-2a95a90af7a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals Inc.
- Application
- ANDA091240
- Marketing category
- ANDA
- Marketing start
- 2021-07-27
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Indomethacin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INDOMETHACIN | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 197817, 197818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72865-148-01 | Indomethacin | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 72865-148-05 | Indomethacin | 500 in 1 BOTTLE | CAPSULE | 500 | | 2 |
| 72865-148-10 | Indomethacin | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 2 |
| 72865-148-30 | Indomethacin | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-148 | INDOMETHACIN (INDOMETHACIN) CAPSULE [XLCARE PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20230117_bc8a572d-e0e1-4d37-b3c4-b85415d50393.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72865-148-01 | 72865014801 | 100 CAPSULE in 1 BOTTLE (72865-148-01) | 100 capsule | 2021-07-27 | 0000-00-00 | No | No | Current |
| 72865-148-05 | 72865014805 | 500 CAPSULE in 1 BOTTLE (72865-148-05) | 500 capsule | 2021-07-27 | 0000-00-00 | No | No | Current |
| 72865-148-10 | 72865014810 | 1000 CAPSULE in 1 BOTTLE (72865-148-10) | 1000 capsule | 2021-07-27 | 0000-00-00 | No | No | Current |
| 72865-148-30 | 72865014830 | 30 CAPSULE in 1 BOTTLE (72865-148-30) | 30 capsule | 2021-07-27 | 0000-00-00 | No | No | Current |