Indomethacin
- Product NDC
- 70954-637
- 11-digit product format
- 709540637
- Labeler code
- 70954
- Product ID
- 70954-637_a2bb8e18-c1c2-4f73-ac4d-139a21488902
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA217883
- Marketing category
- ANDA
- Marketing start
- 2024-01-12
- Substance
- INDOMETHACIN
- Active strength
- 25 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 310991 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-637-10 | Indomethacin | 237 mL in 1 BOTTLE | SUSPENSION | 237 | | 4 |
| 70954-637-10 | Indomethacin | 1 in 1 CARTON | SUSPENSION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-637 | INDOMETHACIN SUSPENSION [ANI PHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20250410_e8b86758-6cb5-44ac-a5fc-2111e98a19a8.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 |
|---|
| 70954-637-10 | 70954063710 | 1 BOTTLE in 1 CARTON (70954-637-10) / 237 mL in 1 BOTTLE | 1 bottle | 2024-01-12 | No | No | Current |