Over-the-counter drug · ANDA
Sinus and Cold D (Naproxen sodium, pseudoephedrine hcl) NDC 41250-417
Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Meijer Distribution Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41250-417-01 | 4125004170141250041701 | 20 BLISTER PACK in 1 CARTON (41250-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 12, 2013 |
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)
- 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
- Labeler
- Meijer Distribution IncNDC labeler code 41250
- 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 41250-417_407e1445-b17b-4ec3-a646-9f0017f254b9SPL ID 407e1445-b17b-4ec3-a646-9f0017f254b9SPL set ID cb78330b-d8a3-4c16-bbb0-d31368a542e6RxCUI 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
N441250041701followed by a unit qualifier and the quantityPackage 41250-0417-01. 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.
About NDC 41250-417
- What is NDC 41250-417?
- 41250-417 is the product NDC for Sinus and Cold D, Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Meijer Distribution Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sinus and Cold D (Naproxen sodium, Pseudoephedrine HCl).
- What is the active ingredient?
- Naproxen sodium, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Meijer Distribution Inc, NDC labeler code 41250. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sinus and Cold D?
- 1 other product NDC are listed under this name. See all Sinus and Cold D NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sinus and Cold D products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 | 51316-0339-01 |
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 Coldnaproxen sodium, pseudeoephedrine hydrochloride | Pseudoephedrine hydrochloride 120 mg/1; Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6090 |
| Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochloride | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6045 |
| 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 |
| Leader All Day Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl | Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0605 |
| 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 |
| 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 |
| 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 |
| 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 |