INDOMETHACIN
- Product NDC
- 50090-0263
- 11-digit product format
- 500900263
- Labeler code
- 50090
- Product ID
- 50090-0263_a1e202aa-d73f-46b3-816b-9f4623a618b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA079175
- Marketing category
- ANDA
- Marketing start
- 2009-03-06
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 75 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
- 2019-12-31
- 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 | 50090-0263 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 50090-0263 | 50090-0263-0 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-0263 | 50090-0263-3 | 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 |
|---|---|---|---|---|---|---|---|
| A079175-001 | INDOMETHACIN | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2009-03-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079175-001 | 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 | A079175-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2009-03-06 | 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 | A079175-001 | 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 | Bryant Ranch Prepack | 41af7776-36bc-4820-b635-e7c69f26997e | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 079175 ANDA079175 |
| Indomethacin | INDOMETHACIN | American Health Packaging | 5a65b650-ea9b-4d0d-b62f-5971df1e62b4 | 2025-10-28 | Warnings, Adverse reactions | 079175 ANDA079175 |
| INDOMETHACIN | INDOMETHACIN | PD-Rx Pharmaceuticals, Inc. | 85014b51-1354-4d16-9995-3ee33a7155fa | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | 079175 ANDA079175 |
| INDOMETHACIN | INDOMETHACIN | KVK-Tech, Inc. | dc80228c-acae-44dc-9762-19bd1669bf45 | 2025-03-18 | Boxed warning, Warnings, Adverse reactions | 079175 ANDA079175 |