Prescription drug · ANDA
Naproxen Sodium NDC 71335-0822
Naproxen sodium 550 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0822-0 | 71335082200 | 6 TABLET, FILM COATED in 1 BOTTLE (71335-0822-0)Marketed from Jan 29, 2025 | |
| 71335-0822-1 | 71335082201 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-0822-1)Marketed from Feb 21, 2020 | |
| 71335-0822-2 | 71335082202 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0822-2)Marketed from Jan 29, 2025 | |
| 71335-0822-3 | 71335082203 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0822-3)Marketed from Aug 23, 2018 | |
| 71335-0822-4 | 71335082204 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0822-4)Marketed from May 29, 2018 | |
| 71335-0822-5 | 71335082205 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0822-5)Marketed from Apr 26, 2018 | |
| 71335-0822-6 | 71335082206 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0822-6)Marketed from Jan 29, 2025 | |
| 71335-0822-7 | 71335082207 | 42 TABLET, FILM COATED in 1 BOTTLE (71335-0822-7)Marketed from Jan 29, 2025 | |
| 71335-0822-8 | 71335082208 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-0822-8)Marketed from Jan 29, 2025 | |
| 71335-0822-9 | 71335082209 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-0822-9)Marketed from Jan 29, 2025 |
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)
- Naproxen Sodium
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 550 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-0822_25e161db-5f02-4458-bec7-b5a99f425a19SPL ID 25e161db-5f02-4458-bec7-b5a99f425a19SPL set ID 0e7697ad-25c6-4405-9f9b-791633cb1ef7RxCUI 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
N471335082200followed by a unit qualifier and the quantityPackage 71335-0822-00. 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.
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 275 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1925 |
| Naproxen Sodium | Naproxen sodium 275 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-515 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-516 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-479 |