NDC codes

FDA NDC Directory
Product NDC (as listed)0573-2160Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00573-2160Add 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
0573-2160-7400573216074005732160742 CARTON in 1 PACKAGE (0573-2160-74) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACKMarketed from Jan 1, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Advil Cold And Sinus
Generic name (nonproprietary)
ibuprofen and pseudoephedrine hydrochloride
Active ingredients
Ibuprofen — 200 mg/1Pseudoephedrine hydrochloride — 30 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Haleon US Holdings LLCNDC labeler code 0573
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 019771
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0573-2160_cec76100-19bc-49c3-8805-7badb2a8bf28SPL ID cec76100-19bc-49c3-8805-7badb2a8bf28SPL set ID fac22a47-f0de-4505-fd8a-768430cda0c1RxCUI 1299021UNII WK2XYI10QM, 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

N400573216074 followed by a unit qualifier and the quantity

Package 00573-2160-74. 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 symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0573-2160

What is NDC 0573-2160?
0573-2160 is the product NDC for Advil Cold And Sinus, Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 tablet, coated, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Advil Cold And Sinus (Ibuprofen and pseudoephedrine hydrochloride).
What is the active ingredient?
Ibuprofen, Pseudoephedrine hydrochloride.
Who is the labeler?
Haleon US Holdings LLC, NDC labeler code 0573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Advil Cold And Sinus?
2 other product NDCs are listed under this name. See all Advil Cold And Sinus 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 Advil Cold And Sinus NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Advil Cold And Sinusibuprofen, pseudoephedrine hydrochlorideIbuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1Capsule, Liquid filledOralHaleon US Holdings LLC0573-018400573-0184-1600573-0184-32
Advil Cold And Sinusibuprofen and pseudoephedrine hydrochlorideIbuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1Tablet, CoatedOralHaleon US Holdings LLC0573-018000573-0180-1000573-0180-2100573-0180-80

Other NDCs under NDA 019771

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

FDA NDC Directory listings under NDA 019771
ProductStrengthForm · routeLabelerProduct NDC
Advil Cold And Sinusibuprofen and pseudoephedrine hydrochlorideIbuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1Tablet, CoatedOralHaleon US Holdings LLC0573-0180

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