Prescription drug · ANDA
Indomethacin NDC 65162-506
Indomethacin 75 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-506-03 | 6516205060365162050603 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03)Marketed from Dec 6, 2010 | |
| 65162-506-06 | 6516205060665162050606 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06)Marketed from Dec 6, 2010 | |
| 65162-506-09 | 6516205060965162050609 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09)Marketed from Dec 6, 2010 | |
| 65162-506-10 | 6516205061065162050610 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10)Marketed from Dec 6, 2010 | |
| 65162-506-11 | 6516205061165162050611 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11)Marketed from Dec 6, 2010 | |
| 65162-506-50 | 6516205065065162050650 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50)Marketed from Dec 6, 2010 |
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
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091549
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4SPL ID 083ef389-551a-48c5-9a92-f16fb6270ae4SPL set ID dbad7e61-2347-43b1-a422-9183e41c10eaRxCUI 310992UNII XXE1CET956UPC 0365162506105
- 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
N465162050603followed by a unit qualifier and the quantityPackage 65162-0506-03. 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 65162-506
- What is NDC 65162-506?
- 65162-506 is the product NDC for Indomethacin, Indomethacin 75 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 6 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?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 |