NDC codes

FDA NDC Directory
Product NDC (as listed)67751-150Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67751-0150Add 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
67751-150-01677510150011 POUCH in 1 CARTON (67751-150-01) / 1 TABLET, COATED in 1 POUCHMarketed from Sep 20, 2016
67751-150-02677510150021 POUCH in 1 CARTON (67751-150-02) / 2 TABLET, COATED in 1 POUCHMarketed from Sep 20, 2016

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

Generic name (nonproprietary)
ibuprofen, phenylephrine hydrochloride
Active ingredients
Ibuprofen — 200 mg/1Phenylephrine hydrochloride — 10 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Navajo Manufacturing Company Inc.NDC labeler code 67751
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022565
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 67751-150_f6f7501a-9ba4-82ea-e053-6294a90a298eSPL ID f6f7501a-9ba4-82ea-e053-6294a90a298eSPL set ID 531abadc-37fd-4953-95bc-a211a2ba6914RxCUI 1369775UNII WK2XYI10QM, 04JA59TNSJ
Pharmacologic class
Nonsteroidal Anti-inflammatory Drug; alpha-1 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

N467751015001 followed by a unit qualifier and the quantity

Package 67751-0150-01. 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 symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67751-150

What is NDC 67751-150?
67751-150 is the product NDC for Advil Sinus Congestion and Pain Relief, Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by Navajo Manufacturing Company Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Advil Sinus Congestion and Pain Relief (Ibuprofen, Phenylephrine hydrochloride).
What is the active ingredient?
Ibuprofen, Phenylephrine hydrochloride.
Who is the labeler?
Navajo Manufacturing Company Inc., NDC labeler code 67751. 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 Sinus Congestion and Pain Relief?
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 022565

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

FDA NDC Directory listings under NDA 022565
ProductStrengthForm · routeLabelerProduct NDC
Advil Sinus Congestion And Painibuprofen, phenylephrine hydrochlorideIbuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1Tablet, CoatedOralHaleon US Holdings LLC0573-0199

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