Over-the-counter drug · ANDA
Naproxen Sodium Caplets (naproxen sodium) NDC 43598-058
Naproxen sodium 220 mg/1 · Tablet, Coated · Oral · Dr Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-058-29 | 43598005829 | 200 TABLET, COATED in 1 BOTTLE (43598-058-29)Marketed from Aug 4, 2021 |
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 CapletsSuffix: Caplets
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Dr Reddy's Laboratories Inc
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075168
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-058_4c8d85dc-7bf0-a540-f37f-d1f91ff908f9SPL ID 4c8d85dc-7bf0-a540-f37f-d1f91ff908f9SPL set ID ee0463bc-e939-1ecf-5a86-d045c426fecfRxCUI 849574UNII 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
N443598005829followed by a unit qualifier and the quantityPackage 43598-0058-29. 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 .
Indications (excerpt from the label)
Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075168
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 220 mg/1 | Tablet, CoatedOral | SAM'S WEST INC | 68196-255 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Kroger Company | 30142-954 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Limited | 55111-273 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Limited | 55111-272 |
| Naproxen Sodium Headache Pain Capletsnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-059 |
| Naproxen Sodium Back and Muscle Pain Capletsnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-060 |
| Naproxen Sodium Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-073 |
| Naproxen Sodium Headache Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-071 |
| Naproxen Sodium Headache Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-072 |
| Naproxen Sodium Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-074 |