Prescription drug · ANDA
Naproxen Sodium NDC 63629-8516
Naproxen sodium 550 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8516-1 | 63629851601 | 500 TABLET in 1 BOTTLE (63629-8516-1)Marketed from Oct 30, 2019 |
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
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212199
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-8516_5c995236-3a38-45a1-8db2-8c59960a0554SPL ID 5c995236-3a38-45a1-8db2-8c59960a0554SPL set ID bee7b482-8ba5-411d-90ee-de00df50d2b7RxCUI 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
N463629851601followed by a unit qualifier and the quantityPackage 63629-8516-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 212199
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 | TabletOral | Asclemed USA, Inc. | 76420-627 |
| Naproxen Sodium | Naproxen sodium 275 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-637 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Proficient Rx LP | 71205-631 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8517 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-801 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0531 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2333 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-389 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0574 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9663 |
| Naproxen Sodium | Naproxen sodium 275 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-432 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-433 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7800 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Direct Rx | 72189-332 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2294 |