Indomethacin
- Product NDC
- 68788-8092
- 11-digit product format
- 687888092
- Labeler code
- 68788
- Product ID
- 68788-8092_4d02d668-37e5-41be-ba3c-a9b8429cb10a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA091240
- Marketing category
- ANDA
- Marketing start
- 2021-10-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Indomethacin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INDOMETHACIN | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 197817 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8092-2 | Indomethacin | 20 in 1 BOTTLE | CAPSULE | 20 | | 6 |
| 68788-8092-3 | Indomethacin | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8092 | INDOMETHACIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240526_3785c914-0037-49ef-b6f5-a5e868ae490b.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 |
|---|
| 68788-8092-2 | 68788809202 | 20 CAPSULE in 1 BOTTLE (68788-8092-2) | 20 capsule | 2021-10-05 | 0000-00-00 | No | No | Current |
| 68788-8092-3 | 68788809203 | 30 CAPSULE in 1 BOTTLE (68788-8092-3) | 30 capsule | 2021-10-05 | 0000-00-00 | No | No | Current |