Indomethacin
- Product NDC
- 70771-1766
- 11-digit product format
- 707711766
- Labeler code
- 70771
- Product ID
- 70771-1766_6d0a7b56-9d42-4fe8-9166-408267ded644
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA216184
- Marketing category
- ANDA
- Marketing start
- 2023-08-03
- 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 |
|---|
| 70771-1766-6 | Indomethacin | 6 in 1 BLISTER PACK | SUPPOSITORY | 6 | | 1 |
| 70771-1766-7 | Indomethacin | 5 in 1 CARTON | SUPPOSITORY | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1766 | INDOMETHACIN SUPPOSITORY [ZYDUS LIFESCIENCES LIMITED] | 1 | Current NDC, 2 package rows | 20230804_c6ca86fb-df23-42c1-9d29-f15312faf60c.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 |
|---|
| 70771-1766-6 | 70771176606 | 6 in 1 BLISTER PACK | | | | | Historical |
| 70771-1766-7 | 70771176607 | 5 BLISTER PACK in 1 CARTON (70771-1766-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70771-1766-6) | 5 blister pack | 2023-08-03 | No | No | Historical |