Prescription drug · ANDA
Naproxen Sodium NDC 76420-627
Naproxen sodium 550 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-627-01 | 7642006270176420062701 | 100 TABLET in 1 BOTTLE (76420-627-01)Marketed from Oct 18, 2023 | |
| 76420-627-30 | 7642006273076420062730 | 30 TABLET in 1 BOTTLE (76420-627-30)Marketed from Oct 18, 2023 | |
| 76420-627-60 | 7642006276076420062760 | 60 TABLET in 1 BOTTLE (76420-627-60)Marketed from Oct 18, 2023 | |
| 76420-627-90 | 7642006279076420062790 | 90 TABLET in 1 BOTTLE (76420-627-90)Marketed from Oct 18, 2023 |
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 Sodium
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 550 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 212199
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-627_07f76fa9-dba3-997b-e063-6294a90a6dd5SPL ID 07f76fa9-dba3-997b-e063-6294a90a6dd5SPL set ID b0571e62-9330-438d-a2ba-873477f52dc4RxCUI 849398, 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
N476420062701followed by a unit qualifier and the quantityPackage 76420-0627-01. 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 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 sodium tablets are also indicated for: the relief of the signs and symptoms of: tendonitis bursitis acute gout the management of: pain primary dysmenorrhea 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 sodium tablets are also indicated for: the relief of the signs and s…
Excerpt only. Read the full label for complete information.
About NDC 76420-627
- What is NDC 76420-627?
- 76420-627 is the product NDC for Naproxen Sodium, Naproxen sodium 550 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium.
- What is the active ingredient?
- Naproxen sodium.
- 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 Sodium?
- 144 other product NDCs are listed under this name. See all Naproxen Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen Sodium 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 sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-988 | 72288-0988-75 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-244 | 57344-0244-03 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0574 | 80425-0574-0180425-0574-0280425-0574-03 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-245 | 42507-0245-0142507-0245-0842507-0245-14 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-844 | 42507-0844-0142507-0844-14 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Capsule, Liquid filledOral | TARGET Corporation | 11673-651 | 11673-0651-78 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Safeway | 21130-593 | 21130-0593-79 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0531 | 80425-0531-0180425-0531-0280425-0531-03 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0532 | 80425-0532-0180425-0532-0280425-0532-03 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-108 | 83324-0108-0183324-0108-2483324-0108-50 |
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 275 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-637 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2294 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Direct Rx | 72189-332 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8516 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8517 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Proficient Rx LP | 71205-631 |
| 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 275 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-432 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0574 |
| 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 | PD-Rx Pharmaceuticals, Inc. | 72789-389 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9663 |