Over-the-counter drug · NDA
Advil Sinus Congestion and Pain Relief (Ibuprofen, phenylephrine hydrochloride) NDC 67751-150
Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1 · Tablet, Coated · Oral · Navajo Manufacturing Company Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67751-150-01 | 67751015001 | 1 POUCH in 1 CARTON (67751-150-01) / 1 TABLET, COATED in 1 POUCHMarketed from Sep 20, 2016 | |
| 67751-150-02 | 67751015002 | 1 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
- Brand name (proprietary)
- Advil Sinus Congestion and Pain Relief
- 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
N467751015001followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Advil Sinus Congestion And Painibuprofen, phenylephrine hydrochloride | Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1 | Tablet, CoatedOral | Haleon US Holdings LLC | 0573-0199 |