What is NDC 51316-339?

51316-339 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 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. 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 hydrochloride).

What is the active ingredient?

Naproxen sodium, Pseudoephedrine hydrochloride.

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, NDC labeler code 51316. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sinus and Cold D NDC 51316-339 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-339Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0339Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
51316-339-01	5131603390151316033901	20 BLISTER PACK in 1 CARTON (51316-339-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 8, 2024

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 hydrochloride
Active ingredients: Naproxen sodium — 220 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNDC labeler code 51316
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076518
Marketing start: May 8, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 51316-339_aadfa695-ca35-49c9-9a72-33f6d2c0a57eSPL ID aadfa695-ca35-49c9-9a72-33f6d2c0a57e
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

N451316033901 followed by a unit qualifier and the quantity

Package 51316-0339-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 51316-339

What is NDC 51316-339?: 51316-339 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 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. 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 hydrochloride).
What is the active ingredient?: Naproxen sodium, Pseudoephedrine hydrochloride.
Who is the labeler?: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, NDC labeler code 51316. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sinus and Cold D NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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	41250-0417-01

Other NDCs under ANDA 076518

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076518
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 hcl	Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Meijer Distribution Inc	41250-417
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