Prescription drug · ANDA
Naproxen NDC 77771-435
Naproxen 375 mg/1 · Tablet · Oral · Radha Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77771-435-01 | 77771043501 | 100 TABLET in 1 BOTTLE (77771-435-01)Marketed from Jun 4, 2021 | |
| 77771-435-05 | 77771043505 | 500 TABLET in 1 BOTTLE (77771-435-05)Marketed from Jun 4, 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
- Generic name (nonproprietary)
- naproxen
- Active ingredients
- Naproxen — 375 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Radha Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212517
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 77771-435_3125cb32-f80b-41a2-a05d-e5a35a9c3167SPL ID 3125cb32-f80b-41a2-a05d-e5a35a9c3167SPL set ID 1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170RxCUI 198012, 198013, 198014UNII 57Y76R9ATQUPC 0377771434052, 0377771435059, 0377771435011, 0377771436018
- 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
N477771043501followed by a unit qualifier and the quantityPackage 77771-0435-01. 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 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 tablets are non-steroidal anti-inflammatory drugs 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.
Other NDCs under ANDA 212517
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 | Naproxen 500 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-264 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Proficient Rx LP | 71205-597 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0175 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Radha Pharmaceuticals, Inc. | 77771-436 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Radha Pharmaceuticals, Inc. | 77771-434 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-541 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Direct_Rx | 72189-425 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Medsource Pharmaceuticals | 45865-238 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8511 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-321 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8515 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Medcore LLC | 82461-711 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8512 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8513 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7676 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8514 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1850 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-592 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1869 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-591 |
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