Indomethacin
- Product NDC
- 68071-5269
- 11-digit product format
- 680715269
- Labeler code
- 68071
- Product ID
- 68071-5269_d7716189-8951-0dff-e053-2995a90aad23
- 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
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68071-5269 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68071-5269 | 68071-5269-0 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091276-001 | INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-12-22 | |
| A091276-002 | INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | RS | 2010-12-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091276-001 | AB |
| A091276-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A091276-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-12-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091276-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | RS | 2010-12-22 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A091276-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091276-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Indomethacin | INDOMETHACIN | REMEDYREPACK INC. | bf93022c-a965-49c5-a852-c59e580d7d91 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | PD-Rx Pharmaceuticals, Inc. | 009097a5-2c1e-4f5d-8054-896cf896cb3d | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | PD-Rx Pharmaceuticals, Inc. | 99d7a84b-c755-47be-9d2d-1223162b0a42 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | bf11f5a0-f2ee-499a-8d54-9d557cc66841 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | Preferred Pharmaceuticals Inc. | 1bb80a9f-def3-4228-ab04-a0c2a117a2b9 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | Coupler LLC | 51266787-b50e-bc15-e063-6394a90ad16f | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | St. Mary's Medical Park Pharmacy | 6312c9a6-d4d3-eb1f-e053-2991aa0a5e68 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | PD-Rx Pharmaceuticals, Inc. | b4cf01d1-0d71-4f0f-97a5-07a59744149f | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | REMEDYREPACK INC. | 16238287-d4b0-4afa-8483-1f4ae250a625 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | RedPharm Drug, Inc. | 4d9ef14a-4812-4fcf-e054-00144ff8d46c | 2026-01-24 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | A-S Medication Solutions | 7755391e-ede3-4a32-854c-736dc6dd2ee3 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | A-S Medication Solutions | 927af761-2f37-4e81-a86e-d4fb17cc1897 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | Northwind Health Company, LLC | c9f4eda2-5c8f-72eb-e053-2a95a90a06be | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | Northwind Health Company, LLC | db0f1127-ebd8-636c-e053-2a95a90a4d44 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | Glenmark Pharmaceuticals Inc., USA | f7ed39e2-5431-4e47-935c-c7441d058f94 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | A-S Medication Solutions | 175a2d81-0d0f-46a3-aaaa-1732982d85fd | 2024-11-25 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | 9ce37860-407f-47c7-a64c-62b6cc729298 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | NuCare Pharmaceuticals, Inc. | 503455d9-471e-554f-e054-00144ff88e88 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| INDOMETHACIN | INDOMETHACIN | DIRECT RX | 4d9a253a-f014-4fab-e054-00144ff8d46c | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
| Indomethacin | INDOMETHACIN | Proficient Rx LP | 86c94559-b453-4e61-a76c-6962872f0655 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 091276 ANDA091276 |
FDA-Initiated Inactive NDC Indexing#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-5269-0 | 68071526900 | 100 CAPSULE in 1 BOTTLE (68071-5269-0) | 100 capsule | 2020-06-04 | 0000-00-00 | No | No | Current |