Indomethacin
- Product NDC
- 70710-1958
- 11-digit product format
- 707101958
- Labeler code
- 70710
- Product ID
- 70710-1958_472b97d6-5eef-4fc5-8a01-b5466d00715e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA216184
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- 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 |
|---|
| 70710-1958-6 | Indomethacin | 6 in 1 BLISTER PACK | SUPPOSITORY | 6 | | 3 |
| 70710-1958-7 | Indomethacin | 5 in 1 CARTON | SUPPOSITORY | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1958 | INDOMETHACIN SUPPOSITORY [ZYDUS PHARMACEUTICALS USA INC.] | 3 | Current NDC, 2 package rows | 20241013_7c911ac4-db70-44bf-8374-01c8260aa3d4.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 |
|---|
| 70710-1958-6 | 70710195806 | 6 in 1 BLISTER PACK | | | | | Historical |
| 70710-1958-7 | 70710195807 | 5 BLISTER PACK in 1 CARTON (70710-1958-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6) | 5 blister pack | 2024-04-15 | No | No | Current |