NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0605Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0605Add 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 NDC11-digit (billing)PackageCopy
70000-0605-1700000605017000006050120 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
Labeler
Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
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

N470000060501 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0605

What is NDC 70000-0605?
70000-0605 is the product NDC for Leader All Day Sinus and Cold D, Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader All Day Sinus and Cold D (Naproxen sodium, Pseudoephedrine HCl).
What is the active ingredient?
Naproxen sodium, Pseudoephedrine hydrochloride.
Who is the labeler?
Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leader All Day Sinus and Cold D?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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
ProductStrengthForm · routeLabelerProduct NDC
Aleve-D Sinus and Coldnaproxen sodium, pseudeoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1; Naproxen sodium 220 mg/1TabletOralBayer HealthCare LLC.0280-6090
Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochlorideNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1TabletOralBayer HealthCare LLC.0280-6045
All Day Sinus and Cold Dnaproxen sodium, pseudoephedrine hclNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-0650
Mucinex DS 12HR COLD, FEVER and SINUSnaproxen sodium, pseudoephedrine hydrochlorideNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralReckitt Benckiser LLC72854-223
Sinus and Cold Dnaproxen sodium, pseudoephedrine hclNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-417
Sinus and Cold Dnaproxen sodium, pseudoephedrine hydrochlorideNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-339
Sudafed Sinus 12 Hour Pressure plus Painnaproxen sodium and pseudoephedrine hydrochlorideNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Multilayer, Extended releaseOralKenvue Brands LLC50580-434
Topcare Sinus and Cold Dnaproxen sodium, pseudoephedrine hclNaproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-417

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