Prescription drug · ANDA
Indomethacin NDC 63629-1915
Indomethacin 75 mg/1 · Capsule, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1915-1 | 63629191501 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-1915-1)Marketed from Jan 14, 2021 |
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
- Bryant Ranch Prepack
- 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 63629-1915_a75319fd-57ba-4694-96bc-57aaae08aff5SPL ID a75319fd-57ba-4694-96bc-57aaae08aff5SPL set ID c6126527-5272-4477-8716-d05365a05225RxCUI 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
N463629191501followed by a unit qualifier and the quantityPackage 63629-1915-01. 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)
INDICATIONS & USAGE Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Indomethacin extended-release capsules have been found effective in active stages of the following: 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended-release capsules, USP a…
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 | REMEDYREPACK INC. | 70518-0515 |
| 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 | 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 |