Prescription drug · ANDA
Indomethacin NDC 70954-637
Indomethacin 25 mg/5mL · Suspension · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-637-10 | 7095406371070954063710 | 1 BOTTLE in 1 CARTON (70954-637-10) / 237 mL in 1 BOTTLEMarketed from Jan 12, 2024 |
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/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217883
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70954-637_a2bb8e18-c1c2-4f73-ac4d-139a21488902SPL ID a2bb8e18-c1c2-4f73-ac4d-139a21488902SPL set ID e8b86758-6cb5-44ac-a5fc-2111e98a19a8RxCUI 310991UNII XXE1CET956UPC 0370954637103
- 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
N470954063710followed by a unit qualifier and the quantityPackage 70954-0637-10. 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 Oral Suspension is 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 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 70954-637
- What is NDC 70954-637?
- 70954-637 is the product NDC for Indomethacin, Indomethacin 25 mg/5mL suspension, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 50 mg/1 | SuppositoryRectal | Zydus Pharmaceuticals USA Inc. | 70710-1852 | 70710-1852-07 |
| Indomethacin | Indomethacin 50 mg/1 | SuppositoryRectal | Zydus Lifesciences Limited | 70771-1766 | 70771-1766-07 |