Prescription drug · ANDA
Naproxen Sodium NDC 65862-515
Naproxen sodium 275 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-515-01 | 6586205150165862051501 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-515-01)Marketed from Oct 31, 2011 | |
| 65862-515-05 | 6586205150565862051505 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-515-05)Marketed from Oct 31, 2011 | |
| 65862-515-99 | 6586205159965862051599 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-515-99)Marketed from Oct 31, 2011 |
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 Sodium
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 275 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200629
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-515_a4659cf5-a74b-42b3-968b-a8e4f14f94aaSPL ID a4659cf5-a74b-42b3-968b-a8e4f14f94aaSPL set ID 37b264f9-b46d-4635-8fab-246b1e08b653RxCUI 849398, 849431UNII 9TN87S3A3C
- 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
N465862051501followed by a unit qualifier and the quantityPackage 65862-0515-01. 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)
Naproxen sodium tablets are 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 sodium tablets are non-steroidal anti-inflammatory drugs indicated for: ( 1 ) 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 65862-515
- What is NDC 65862-515?
- 65862-515 is the product NDC for Naproxen Sodium, Naproxen sodium 275 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium.
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 Sodium?
- 141 other product NDCs are listed under this name. See all Naproxen Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| naproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-988 | 72288-0988-75 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0574 | 80425-0574-0180425-0574-0280425-0574-03 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-245 | 42507-0245-0142507-0245-14 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-844 | 42507-0844-0142507-0844-14 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Capsule, Liquid filledOral | TARGET Corporation | 11673-651 | 11673-0651-78 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Safeway | 21130-593 | 21130-0593-79 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0531 | 80425-0531-0180425-0531-0280425-0531-03 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0532 | 80425-0532-0180425-0532-0280425-0532-03 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-108 | 83324-0108-0183324-0108-2483324-0108-50 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-109 | 83324-0109-0183324-0109-50 |
Other NDCs under ANDA 200629
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 |
|---|---|---|---|---|
| Naproxen Sodium | Naproxen sodium 550 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-479 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0822 |
| Naproxen Sodium | Naproxen sodium 275 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1925 |