Prescription drug · ANDA
Naproxen Oral Suspension (Naproxen oral) NDC 70954-151
Naproxen 125 mg/5mL · Suspension · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-151-10 | 70954015110 | 500 mL in 1 BOTTLE (70954-151-10)Marketed from Mar 12, 2021 |
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)
- Naproxen Oral Suspension
- Generic name (nonproprietary)
- naproxen oral
- Active ingredients
- Naproxen — 125 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 211910
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70954-151_1aa670cb-8d65-413a-9bdd-680cafd9b5c4SPL ID 1aa670cb-8d65-413a-9bdd-680cafd9b5c4SPL set ID 252726a7-757a-4b97-b5b8-ffff4ac1d103RxCUI 311913UNII 57Y76R9ATQUPC 0370954151104
- 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
N470954015110followed by a unit qualifier and the quantityPackage 70954-0151-10. 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)
Naproxen oral suspension is indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain. primary dysmenorrhea Naproxen oral suspension is a non-steroidal anti-inflammatory drug indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain. primary dysmenorrhea
Excerpt only. Read the full label for complete information.
About NDC 70954-151
- What is NDC 70954-151?
- 70954-151 is the product NDC for Naproxen Oral Suspension (naproxen oral), Naproxen 125 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?
- Naproxen Oral Suspension (Naproxen oral).
- What is the active ingredient?
- Naproxen.
- 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 Naproxen Oral Suspension?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.