NDC codes

FDA NDC Directory
Product NDC (as listed)63824-041Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63824-0041Add 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
63824-041-24638240041242 BLISTER PACK in 1 CARTON (63824-041-24) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012

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)
Mucinex D Maximum StrengthSuffix: Maximum Strength
Generic name (nonproprietary)
guaifenesin and pseudoephedrine hydrochloride
Active ingredients
Guaifenesin — 1200 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Reckitt Benckiser LLCNDC labeler code 63824
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021585
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 63824-041_4ffd9424-45c5-31f1-e063-6394a90a0521SPL ID 4ffd9424-45c5-31f1-e063-6394a90a0521SPL set ID d9264518-2f2c-498f-b733-6f3397336a01RxCUI 1244675UNII 495W7451VQ, 6V9V2RYJ8N
Pharmacologic class
Expectorant; 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

N463824004124 followed by a unit qualifier and the quantity

Package 63824-0041-24. 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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63824-041

What is NDC 63824-041?
63824-041 is the product NDC for Mucinex D Maximum Strength, Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Reckitt Benckiser LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mucinex D Maximum Strength (Guaifenesin and Pseudoephedrine Hydrochloride).
What is the active ingredient?
Guaifenesin, Pseudoephedrine hydrochloride.
Who is the labeler?
Reckitt Benckiser LLC, NDC labeler code 63824. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mucinex D Maximum Strength?
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 NDA 021585

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

FDA NDC Directory listings under NDA 021585
ProductStrengthForm · routeLabelerProduct NDC
Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralWALGREEN COMPANY0363-0077
Mucinex Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-1075
Mucinex Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-1076
Mucinex Dguaifenesin and pseudoephedrine hydrochlorideGuaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1Tablet, Extended releaseOralReckitt Benckiser LLC63824-057

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in