INDOMETHACIN
- Product NDC
- 0054-1950
- 11-digit product format
- 000541950
- Labeler code
- 0054
- Product ID
- 0054-1950_536da97c-1c9d-4cf8-ae7a-a263cc59c8e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA215899
- Marketing category
- ANDA
- Marketing start
- 2024-11-20
- 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 | 197819 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-1950-30 | INDOMETHACIN | 30 in 1 BOX | SUPPOSITORY | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-1950 | INDOMETHACIN SUPPOSITORY [HIKMA PHARMACEUTICALS USA INC.] | 3 | Current NDC, 1 package rows | 20250125_2033059b-4be1-42d0-b888-34d8202f3e09.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-1950-30 | 00054195030 | 30 SUPPOSITORY in 1 BOX (0054-1950-30) | 30 suppository | 2024-11-20 | No | No | Current |