Indomethacin
- Product NDC
- 55700-536
- Requested package NDC
- 55700-536-30
- 11-digit product format
- 557000536
- Labeler code
- 55700
- Product ID
- 55700-536_8d2f4ecc-9d6c-469c-b6a0-1bff3ce9dd4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA091240
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 25 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
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 package | package | 55700-536 | 55700-536-30 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091240-001 | INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2011-04-12 | |
| A091240-002 | INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2011-04-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091240-001 | AB |
| A091240-002 | 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 | A091240-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2011-04-12 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091240-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2011-04-12 | 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 | A091240-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091240-002 | 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 | St. Mary's Medical Park Pharmacy | 205fc4e7-e118-509e-e063-6394a90a78e6 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | PD-Rx Pharmaceuticals, Inc. | ce866d3a-7bea-4d82-9b7d-79e8a294c141 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | PD-Rx Pharmaceuticals, Inc. | d66ada00-3ece-4b71-8c59-a0db48a2db80 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | A-S Medication Solutions | d2997707-1541-4f5d-8c8d-70b0a13be8b2 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Preferred Pharmaceuticals, Inc. | 3785c914-0037-49ef-b6f5-a5e868ae490b | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| INDOMETHACIN | INDOMETHACIN | DIRECT RX | 7e7175d7-5e43-4151-9702-88ac2cd44ef6 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Northwind Health Company, LLC | dffe9b95-3cb6-4c4e-e053-2a95a90a9328 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Preferred Pharmaceuticals Inc. | 971c4d53-7876-4f42-ba2d-c391714fa341 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | A-S Medication Solutions | 5b05b8bc-4df0-4175-bf53-72129fb21b50 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | a329976b-4a01-42ea-a666-0ac99ed2522e | 2025-09-26 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Camber Pharmaceuticals, Inc. | 1ce9c3c5-0cf7-4760-988d-2559adcfb200 | 2025-05-08 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | 4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | 67b16cf2-e24c-4fe3-8d74-e63549b7659f | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | b1bb9349-21e4-4e6a-9916-3aac6c4d01b8 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | 3fd56b7d-2799-4211-9a58-c6c1dc8c70dc | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | 2f4a5796-5317-4caa-83e4-0595fe844df4 | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | AvPAK | bcaa0e51-a2fc-cf74-027a-1964e38c5e4e | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | 9236d783-d7b8-4486-94c6-5ecd876bc475 | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | 56e19868-3973-4f1b-b80f-1f7daf1f1c22 | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
| Indomethacin | INDOMETHACIN | Bryant Ranch Prepack | afbb24fd-3695-4a30-a8a6-36239e35a14f | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 091240 ANDA091240 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-536-30 | EA - Each | 55700-536 | 7dea6651-9a35-44e5-9f49-e8ac7a0623bc | 1 | 2017-09-11 |
| 55700-536-60 | EA - Each | 55700-536 | f2bbd9a4-85a3-4940-861b-430534139524 | 1 | 2017-09-11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-536-30 | 55700053630 | 30 CAPSULE in 1 BOTTLE (55700-536-30) | 30 capsule | 2017-07-28 | 0000-00-00 | No | No | Current |