Indomethacin
- Product NDC
- 68071-3277
- 11-digit product format
- 680713277
- Labeler code
- 68071
- Product ID
- 68071-3277_1cd4b3ed-b339-77fb-e063-6294a90a7fce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA091276
- Marketing category
- ANDA
- Marketing start
- 2010-12-22
- 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 | 197818 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-3277-2 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-3 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-5 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-6 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-2 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-5 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-2 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-3 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-5 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-6 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
| 68071-3277-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1284-a910-e053-dadaa90a0b85 | Indomethacin Capsules USP, 25 mg and 50 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3277-2 | Indomethacin | 20 in 1 BOTTLE | CAPSULE | 20 | | 6 |
| 68071-3277-3 | Indomethacin | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
| 68071-3277-5 | Indomethacin | 45 in 1 BOTTLE | CAPSULE | 45 | | 6 |
| 68071-3277-6 | Indomethacin | 60 in 1 BOTTLE | CAPSULE | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3277 | INDOMETHACIN CAPSULE [NUCARE PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240711_503455d9-471e-554f-e054-00144ff88e88.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 |
|---|
| 68071-3277-2 | 68071327702 | 20 CAPSULE in 1 BOTTLE (68071-3277-2) | 20 capsule | 2017-05-23 | 0000-00-00 | No | No | Current |
| 68071-3277-3 | 68071327703 | 30 CAPSULE in 1 BOTTLE (68071-3277-3) | 30 capsule | 2017-05-23 | 0000-00-00 | No | No | Current |
| 68071-3277-5 | 68071327705 | 45 CAPSULE in 1 BOTTLE (68071-3277-5) | 45 capsule | 2017-05-23 | 0000-00-00 | No | No | Current |
| 68071-3277-6 | 68071327706 | 60 CAPSULE in 1 BOTTLE (68071-3277-6) | 60 capsule | 2017-05-23 | 0000-00-00 | No | No | Current |