Indomethacin
- Product NDC
- 53002-3500
- 11-digit product format
- 530023500
- Labeler code
- 53002
- Product ID
- 53002-3500_894c9586-d0f9-4a4d-8df4-483e90113203
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA091276
- Marketing category
- ANDA
- Marketing start
- 2010-12-22
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-3500-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-2 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-3 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-2 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-3 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
| 53002-3500-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f9c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-3500-2 | Indomethacin | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
| 53002-3500-3 | Indomethacin | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3500 | INDOMETHACIN CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_da46beba-5693-4c64-b1a8-9ccbe1d38094.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 |
|---|
| 53002-3500-2 | 53002350002 | 20 CAPSULE in 1 BOTTLE (53002-3500-2) | 20 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-3500-3 | 53002350003 | 30 CAPSULE in 1 BOTTLE (53002-3500-3) | 30 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |