Prescription drug · ANDA
Indomethacin NDC 76420-148
Indomethacin 25 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-148-14 | 7642001481476420014814 | 14 CAPSULE in 1 BOTTLE (76420-148-14)Marketed from Jul 25, 2022 | |
| 76420-148-20 | 7642001482076420014820 | 20 CAPSULE in 1 BOTTLE (76420-148-20)Marketed from Jul 25, 2022 | |
| 76420-148-30 | 7642001483076420014830 | 30 CAPSULE in 1 BOTTLE (76420-148-30)Marketed from Jul 25, 2022 | |
| 76420-148-60 | 7642001486076420014860 | 60 CAPSULE in 1 BOTTLE (76420-148-60)Marketed from Jul 25, 2022 | |
| 76420-148-90 | 7642001489076420014890 | 90 CAPSULE in 1 BOTTLE (76420-148-90)Marketed from Jul 25, 2022 |
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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091240
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-148_e49badcf-439d-5511-e053-2995a90a14bfSPL ID e49badcf-439d-5511-e053-2995a90a14bfSPL set ID 9c15102c-b6f9-4198-b592-152160591014RxCUI 197817UNII 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
N476420014814followed by a unit qualifier and the quantityPackage 76420-0148-14. 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 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) • Acute gouty arthritis Indomethacin Capsule is 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) • Acute gouty arthritis ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 76420-148
- What is NDC 76420-148?
- 76420-148 is the product NDC for Indomethacin, Indomethacin 25 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 5 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 091240
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 | Camber Pharmaceuticals, Inc. | 31722-542 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | XLCare Pharmaceuticals Inc. | 72865-149 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-543 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | XLCare Pharmaceuticals Inc. | 72865-148 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0747 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | AvPAK | 50268-430 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-963 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | AvPAK | 50268-431 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8092 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Proficient Rx LP | 63187-282 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8993 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8994 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1299 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1300 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | DIRECT RX | 61919-130 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0051 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0050 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0053 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0992 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4055 |
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