Prescription drug · ANDA
Indomethacin NDC 85766-034
Indomethacin 75 mg/1 · Capsule, Extended release · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-034-00 | 8576600340085766003400 | 10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-00)Marketed from Apr 3, 2026 | |
| 85766-034-01 | 8576600340185766003401 | 1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-01)Marketed from Aug 7, 2025 | |
| 85766-034-02 | 8576600340285766003402 | 2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-02)Marketed from Aug 7, 2025 | |
| 85766-034-06 | 8576600340685766003406 | 6 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-06)Marketed from Aug 17, 2026 | |
| 85766-034-07 | 8576600340785766003407 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-07)Marketed from Aug 7, 2025 | |
| 85766-034-10 | 8576600341085766003410 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-10)Marketed from Aug 7, 2025 | |
| 85766-034-14 | 8576600341485766003414 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-14)Marketed from Aug 7, 2025 | |
| 85766-034-20 | 8576600342085766003420 | 20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-20)Marketed from Aug 7, 2025 | |
| 85766-034-30 | 8576600343085766003430 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-30)Marketed from Aug 7, 2025 | |
| 85766-034-60 | 8576600346085766003460 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-60)Marketed from Aug 7, 2025 | |
| 85766-034-90 | 8576600349085766003490 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-90)Marketed from Aug 7, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Indomethacin
- Generic name (nonproprietary)
- indomethacin
- Active ingredients
- Indomethacin — 75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Sportpharm LLCNDC labeler code 85766
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201807
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 85766-034_59413a4c-b487-26f8-e063-6394a90aed07SPL ID 59413a4c-b487-26f8-e063-6394a90aed07SPL set ID 12821a3a-b5f2-4415-84c9-0a30a4725f1eRxCUI 310992UNII XXE1CET956
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485766003400followed by a unit qualifier and the quantityPackage 85766-0034-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Indomethacin extended-release capsules are indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 85766-034
- What is NDC 85766-034?
- 85766-034 is the product NDC for Indomethacin, Indomethacin 75 mg/1 capsule, extended release, listed with the FDA by Sportpharm LLC. It has 11 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Indomethacin.
- What is the active ingredient?
- Indomethacin.
- Who is the labeler?
- Sportpharm LLC, NDC labeler code 85766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Indomethacin?
- 79 other product NDCs are listed under this name. See all Indomethacin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Indomethacin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Coupler LLC | 67046-0416 | 67046-0416-03 |
| Indomethacin | Indomethacin 50 mg/1 | SuppositoryRectal | NorthStar RxLLC | 72603-281 | 72603-0281-30 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4055 | 68788-4055-03 |
| Indomethacin | Indomethacin 50 mg/1 | SuppositoryRectal | Camber Pharmaceuticals, Inc. | 31722-051 | 31722-0051-31 |
| Indomethacin | Indomethacin 50 mg/1 | SuppositoryRectal | Amneal Pharmaceuticals NY LLC | 69238-2086 | 69238-2086-03 |
| Indomethacin | Indomethacin 50 mg/1 | SuppositoryRectal | Hikma Pharmaceuticals USA Inc. | 0054-1950 | 00054-1950-30 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-916 | 60760-0916-2160760-0916-30 |
| Indomethacin | Indomethacin 50 mg/1 | SuppositoryRectal | Zydus Pharmaceuticals USA Inc. | 70710-1958 | 70710-1958-07 |
| Indomethacin | Indomethacin 25 mg/5mL | SuspensionOral | ANI Pharmaceuticals, Inc. | 70954-637 | 70954-0637-10 |
| Indomethacin | Indomethacin 50 mg/1 | SuppositoryRectal | Zydus Pharmaceuticals USA Inc. | 70710-1852 | 70710-1852-07 |
Other NDCs under ANDA 201807
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-565 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Northwind Health Company, LLC | 51655-443 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-1915 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-0515 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-822 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-0756 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1302 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Asclemed USA, Inc. | 76420-029 |
| Indomethacin ERindomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0271 |