Prescription drug · ANDA
Indomethacin NDC 70518-0515
Indomethacin 75 mg/1 · Capsule, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0515-2 | 70518051502 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0515-2)Marketed from Mar 10, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.
- 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 70518-0515_552ac822-6748-9a8f-e063-6394a90a5ce3SPL ID 552ac822-6748-9a8f-e063-6394a90a5ce3SPL set ID b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30RxCUI 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
N470518051502followed by a unit qualifier and the quantityPackage 70518-0515-02. 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.
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 | Sportpharm LLC | 85766-034 |
| Indomethacin ERindomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0271 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-565 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Asclemed USA, Inc. | 76420-029 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-1915 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-0756 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-822 |
| 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 | 72162-1302 |