Indomethacin
- Product NDC
- 76420-029
- 11-digit product format
- 764200029
- Labeler code
- 76420
- Product ID
- 76420-029_ead13cff-b9d2-cdc1-e053-2a95a90adf09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA201807
- Marketing category
- ANDA
- Marketing start
- 2015-07-24
- Substance
- INDOMETHACIN
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 310992 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-029-01 | Indomethacin | 1 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1 | | 2 |
| 76420-029-02 | Indomethacin | 2 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 2 | | 2 |
| 76420-029-07 | Indomethacin | 7 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 7 | | 2 |
| 76420-029-14 | Indomethacin | 14 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 14 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-029 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20221013_dfdcdb27-07a0-47e6-b8da-d9c99045a066.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-029-01 | 76420002901 | 1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-01) | 2020-02-11 | 0000-00-00 | No | No | Current |
| 76420-029-02 | 76420002902 | 2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-02) | 2020-02-11 | 0000-00-00 | No | No | Current |
| 76420-029-07 | 76420002907 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-07) | 2020-02-11 | 0000-00-00 | No | No | Current |
| 76420-029-14 | 76420002914 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-14) | 2020-02-11 | 0000-00-00 | No | No | Current |