INDOMETHACIN
- Product NDC
- 61919-164
- 11-digit product format
- 619190164
- Labeler code
- 61919
- Product ID
- 61919-164_151f8422-70b3-cf70-e063-6294a90a90fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- INDOMETHACIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA091276
- Marketing category
- ANDA
- Marketing start
- 2017-04-20
- Substance
- INDOMETHACIN
- Active strength
- 50 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 | 50 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 |
|---|
| 61919-164-21 | INDOMETHACIN | 21 in 1 BOTTLE | CAPSULE | 21 | | 7 |
| 61919-164-30 | INDOMETHACIN | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-164 | INDOMETHACIN CAPSULE [DIRECT RX] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240403_4d9a253a-f014-4fab-e054-00144ff8d46c.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 |
|---|
| 61919-164-21 | 61919016421 | 21 CAPSULE in 1 BOTTLE (61919-164-21) | 21 capsule | 2017-04-20 | 0000-00-00 | No | No | Current |
| 61919-164-30 | 61919016430 | 30 CAPSULE in 1 BOTTLE (61919-164-30) | 30 capsule | 2017-04-20 | 0000-00-00 | No | No | Current |