Prescription drug · ANDA
Naproxen NDC 50228-436
Naproxen 500 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-436-01 | 50228043601 | 100 TABLET in 1 BOTTLE (50228-436-01)Marketed from Mar 1, 2020 | |
| 50228-436-05 | 50228043605 | 500 TABLET in 1 BOTTLE (50228-436-05)Marketed from Mar 1, 2020 | |
| 50228-436-10 | 50228043610 | 1000 TABLET in 1 BOTTLE (50228-436-10)Marketed from Mar 1, 2020 | |
| 50228-436-30 | 50228043630 | 30 TABLET in 1 BOTTLE (50228-436-30)Marketed from Mar 1, 2020 |
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
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
- 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 50228-436_9af8c9f3-92e7-4301-b401-f40230af2eb7SPL ID 9af8c9f3-92e7-4301-b401-f40230af2eb7SPL set ID 81e22c1f-f94d-46e9-8b7d-72dc2518319eRxCUI 198012, 198013, 198014UNII 57Y76R9ATQUPC 0350228435017, 0350228434010, 0350228436014
- 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
N450228043601followed by a unit qualifier and the quantityPackage 50228-0436-01. 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.
About NDC 50228-436
- What is NDC 50228-436?
- 50228-436 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen.
- What is the active ingredient?
- Naproxen.
- Who is the labeler?
- ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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?
- 184 other product NDCs are listed under this name. See all Naproxen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen 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 | Naproxen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4750 | 70518-4750-00 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0784 | 67046-0784-03 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Coupler LLC | 67046-0499 | 67046-0499-03 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Coupler LLC | 67046-0500 | 67046-0500-03 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0501 | 67046-0501-03 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-211 | 11534-0211-01 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-212 | 11534-0212-01 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4514 | 70518-4514-00 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Medcore LLC | 82461-711 | 82461-0711-60 |
| Naproxen | Naproxen 125 mg/5mL | SuspensionOral | Aurobindo Pharma Limited | 59651-528 | 59651-0528-47 |
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 375 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-644 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0058 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0175 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0023 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0024 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7946 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-564 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Radha Pharmaceuticals, Inc. | 77771-434 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Radha Pharmaceuticals, Inc. | 77771-435 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Radha Pharmaceuticals, Inc. | 77771-436 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Proficient Rx LP | 71205-597 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3822 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Medcore LLC | 82461-711 |
| 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 | Bryant Ranch Prepack | 71335-1850 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-321 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Medsource Pharmaceuticals | 45865-238 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1869 |
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