Indomethacin
- Product NDC
- 50090-0050
- 11-digit product format
- 500900050
- Labeler code
- 50090
- Product ID
- 50090-0050_7dfbcb28-6d02-4391-acb6-a0ce06ee90a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA091240
- Marketing category
- ANDA
- Marketing start
- 2016-05-19
- 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
- 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 197817, 197818 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-0050-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-5 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-5 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-5 | 2023-02-07 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
| 50090-0050-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-a640-0266-e053-dadaa90a7c1a | 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 |
|---|
| 50090-0050-0 | Indomethacin | 21 in 1 BOTTLE | CAPSULE | 21 | | 33 |
| 50090-0050-1 | Indomethacin | 30 in 1 BOTTLE | CAPSULE | 30 | | 33 |
| 50090-0050-3 | Indomethacin | 90 in 1 BOTTLE | CAPSULE | 90 | | 33 |
| 50090-0050-5 | Indomethacin | 15 in 1 BOTTLE | CAPSULE | 15 | | 33 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-0050 | INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS] | 27 | Current NDC, Legacy NDC, 4 package rows | 20250403_d2997707-1541-4f5d-8c8d-70b0a13be8b2.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 |
|---|
| 50090-0050-0 | 50090005000 | 21 CAPSULE in 1 BOTTLE (50090-0050-0) | 21 capsule | 2016-05-19 | 0000-00-00 | No | No | Current |
| 50090-0050-1 | 50090005001 | 30 CAPSULE in 1 BOTTLE (50090-0050-1) | 30 capsule | 2016-05-19 | 0000-00-00 | No | No | Current |
| 50090-0050-3 | 50090005003 | 90 CAPSULE in 1 BOTTLE (50090-0050-3) | 90 capsule | 2016-05-19 | 0000-00-00 | No | No | Current |
| 50090-0050-5 | 50090005005 | 15 in 1 BOTTLE | | | | | | Historical |