Prescription drug · ANDA
Indomethacin NDC 67296-0886
Indomethacin 50 mg/1 · Capsule · Oral · RedPharm Drug, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-0886-1 | 6729608860167296088601 | 15 CAPSULE in 1 BOTTLE (67296-0886-1)Marketed from Dec 22, 2010 | |
| 67296-0886-2 | 6729608860267296088602 | 20 CAPSULE in 1 BOTTLE (67296-0886-2)Marketed from Dec 22, 2010 | |
| 67296-0886-6 | 6729608860667296088606 | 60 CAPSULE in 1 BOTTLE (67296-0886-6)Marketed from Dec 22, 2010 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- RedPharm Drug, Inc.NDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091276
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 67296-0886_4922a60e-ae81-cd44-e063-6394a90af540SPL ID 4922a60e-ae81-cd44-e063-6394a90af540SPL set ID 4d9ef14a-4812-4fcf-e054-00144ff8d46cRxCUI 197818UNII XXE1CET956UPC 0367296088663
- 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
N467296088601followed by a unit qualifier and the quantityPackage 67296-0886-01. 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 AND USAGE Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin 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). 5. Acute gouty arthritis.
Excerpt only. Read the full label for complete information.
About NDC 67296-0886
- What is NDC 67296-0886?
- 67296-0886 is the product NDC for Indomethacin, Indomethacin 50 mg/1 capsule, listed with the FDA by RedPharm Drug, Inc.. It has 3 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?
- RedPharm Drug, Inc., NDC labeler code 67296. 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 091276
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 25 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-368 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-929 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-930 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0054 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0055 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2803 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2987 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-329 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-596 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-294 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | DIRECT RX | 61919-164 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | DIRECT RX | 61919-526 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Proficient Rx LP | 63187-948 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Coupler LLC | 67046-0416 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3277 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-302 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-406 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-6448 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1458 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1512 |
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