Prescription drug · ANDA
Naproxen NDC 76420-787
Naproxen 250 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-787-01 | 76420078701 | 1 TABLET in 1 BOTTLE (76420-787-01)Marketed from Mar 19, 2024 | |
| 76420-787-02 | 76420078702 | 2 TABLET in 1 BOTTLE (76420-787-02)Marketed from Mar 19, 2024 | |
| 76420-787-05 | 76420078705 | 500 TABLET in 1 BOTTLE (76420-787-05)Marketed from Mar 19, 2024 | |
| 76420-787-07 | 76420078707 | 7 TABLET in 1 BOTTLE (76420-787-07)Marketed from Mar 19, 2024 | |
| 76420-787-10 | 76420078710 | 100 TABLET in 1 BOTTLE (76420-787-10)Marketed from Mar 19, 2024 | |
| 76420-787-14 | 76420078714 | 14 TABLET in 1 BOTTLE (76420-787-14)Marketed from Mar 19, 2024 | |
| 76420-787-20 | 76420078720 | 20 TABLET in 1 BOTTLE (76420-787-20)Marketed from Mar 19, 2024 | |
| 76420-787-30 | 76420078730 | 30 TABLET in 1 BOTTLE (76420-787-30)Marketed from Mar 19, 2024 | |
| 76420-787-60 | 76420078760 | 60 TABLET in 1 BOTTLE (76420-787-60)Marketed from Mar 19, 2024 | |
| 76420-787-90 | 76420078790 | 90 TABLET in 1 BOTTLE (76420-787-90)Marketed from Mar 19, 2024 |
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 — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- 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 76420-787_14060e9c-4605-5493-e063-6294a90ab6d3SPL ID 14060e9c-4605-5493-e063-6294a90ab6d3SPL set ID 5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4bRxCUI 198012, 198013UNII 57Y76R9ATQ
- 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
N476420078701followed by a unit qualifier and the quantityPackage 76420-0787-01. 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 76420-787
- What is NDC 76420-787?
- 76420-787 is the product NDC for Naproxen, Naproxen 250 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 10 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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?
- 185 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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