Prescription drug · ANDA
Naproxen NDC 11534-212
Naproxen 500 mg/1 · Tablet, Delayed release · Oral · Sunrise Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11534-212-01 | 11534021201 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (11534-212-01)Marketed from Dec 9, 2025 |
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
- Sunrise Pharmaceutical, 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 11534-212_502c7695-7f9d-4893-b151-65111de2e2a7SPL ID 502c7695-7f9d-4893-b151-65111de2e2a7SPL set ID f2fb222a-b854-4e6f-9027-2e08aed24185RxCUI 311915, 603103UNII 57Y76R9ATQUPC 0311534212013, 0311534211016
- 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
N411534021201followed by a unit qualifier and the quantityPackage 11534-0212-01. 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 delayed-release tablets are indicated for: The relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis Naproxen delayed-release tablets are non-steroidal anti-inflammatory drugs indicated for ( 1 ): the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis
Excerpt only. Read the full label for complete information.
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 500 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-003 |
| 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 | TabletOral | Cameron Pharmaceuticals | 42494-454 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-453 |