Prescription drug · ANDA
Naproxen NDC 71335-0217
Naproxen 250 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0217-1 | 71335021701 | 30 TABLET in 1 BOTTLE (71335-0217-1)Marketed from Apr 20, 2018 | |
| 71335-0217-2 | 71335021702 | 60 TABLET in 1 BOTTLE (71335-0217-2)Marketed from Feb 15, 2018 | |
| 71335-0217-3 | 71335021703 | 20 TABLET in 1 BOTTLE (71335-0217-3)Marketed from Sep 5, 2024 | |
| 71335-0217-4 | 71335021704 | 120 TABLET in 1 BOTTLE (71335-0217-4)Marketed from Sep 5, 2024 | |
| 71335-0217-5 | 71335021705 | 10 TABLET in 1 BOTTLE (71335-0217-5)Marketed from Sep 5, 2024 | |
| 71335-0217-6 | 71335021706 | 90 TABLET in 1 BOTTLE (71335-0217-6)Marketed from Sep 5, 2024 | |
| 71335-0217-7 | 71335021707 | 40 TABLET in 1 BOTTLE (71335-0217-7)Marketed from Sep 5, 2024 | |
| 71335-0217-8 | 71335021708 | 45 TABLET in 1 BOTTLE (71335-0217-8)Marketed from Sep 5, 2024 |
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
- Generic name (nonproprietary)
- naproxen
- Active ingredients
- Naproxen — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078250
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0217_fb26cc76-51bd-49de-9161-c8489d7a1c2cSPL ID fb26cc76-51bd-49de-9161-c8489d7a1c2cSPL set ID da61463f-f87b-4aba-b538-7264252cadb8RxCUI 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
N471335021701followed by a unit qualifier and the quantityPackage 71335-0217-01. 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 and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea Naproxen tablets and naproxen sodium 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 Naproxen tablets and naproxen sodium t…
Excerpt only. Read the full label for complete information.
About NDC 71335-0217
- What is NDC 71335-0217?
- 71335-0217 is the product NDC for Naproxen, Naproxen 250 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 8 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 078250
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 | A-S Medication Solutions | 50090-0481 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-0482 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-0483 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-1583 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-1584 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-1585 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-2788 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7198 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | American Health Packaging | 60687-491 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Proficient Rx LP | 63187-028 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Proficient Rx LP | 63187-461 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Proficient Rx LP | 63187-535 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-153 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-807 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Coupler LLC | 67046-0499 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Coupler LLC | 67046-0500 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0501 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-188 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-189 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-190 |
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