Over-the-counter drug · ANDA
Leader All Day Sinus and Cold D NDC 70000-0605
naproxen sodium, pseudoephedrine hcl · Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0605-1 | 70000060501 | 20 BLISTER PACK in 1 CARTON (70000-0605-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 19, 2022 |
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)
- Leader All Day Sinus and Cold D
- Generic name (nonproprietary)
- naproxen sodium, pseudoephedrine hcl
- Active ingredients
- Naproxen sodium — 220 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076518
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70000-0605_4d33af2f-53b6-49d2-927b-55d7f9273103SPL ID 4d33af2f-53b6-49d2-927b-55d7f9273103SPL set ID 83f7cfbb-ab84-4594-ae7a-4a657385c8a7RxCUI 1367426UNII 9TN87S3A3C, 6V9V2RYJ8N
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; alpha-Adrenergic Agonist
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
N470000060501followed by a unit qualifier and the quantityPackage 70000-0605-01. 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 .
Indications (excerpt from the label)
Uses temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076518
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 |
|---|---|---|---|---|
| Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6045 |
| Mucinex DS 12HR COLD, FEVER and SINUSnaproxen sodium, pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Reckitt Benckiser LLC | 72854-223 |
| Aleve-D Sinus and Coldnaproxen sodium, pseudeoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1; Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6090 |
| All Day Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-0650 |
| Sudafed Sinus 12 Hour Pressure plus Painnaproxen sodium and pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Multilayer, Extended releaseOral | Kenvue Brands LLC | 50580-434 |
| Sinus and Cold Dnaproxen sodium, pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-339 |
| Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Meijer Distribution Inc | 41250-417 |
| Topcare Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-417 |