Prescription drug · ANDA
Naproxen NDC 72789-003
Naproxen 500 mg/1 · Tablet, Delayed release · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-003-60 | 72789000360 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-003-60)Marketed from Aug 20, 2019 |
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 — 500 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091432
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 72789-003_4030dd59-8cd7-cfbe-e063-6294a90aad75SPL ID 4030dd59-8cd7-cfbe-e063-6294a90aad75SPL set ID 2d01e583-670a-46f4-b5f2-3fad46d0376fRxCUI 311915UNII 57Y76R9ATQUPC 0372789003603
- 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
N472789000360followed by a unit qualifier and the quantityPackage 72789-0003-60. 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 091432
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 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 66267-373 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-060 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2275 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2276 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Cipla USA Inc. | 69097-851 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | Cipla USA Inc. | 69097-852 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-211 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-212 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-454 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-453 |