Over-the-counter drug · NDA
Advil Sinus Congestion And Pain NDC 0573-0199
ibuprofen, phenylephrine hydrochloride · Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1 · Tablet, Coated · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-0199-01 | 00573019901 | 50 POUCH in 1 TRAY (0573-0199-01) / 1 TABLET, COATED in 1 POUCHMarketed from Jul 1, 2015 | |
| 0573-0199-03 | 00573019903 | 3000 POUCH in 1 CARTON (0573-0199-03) / 1 TABLET, COATED in 1 POUCHMarketed from Jul 1, 2015 | |
| 0573-0199-11 | 00573019911 | 10 BLISTER PACK in 1 CARTON (0573-0199-11) / 1 TABLET, COATED in 1 BLISTER PACKMarketed from Jul 1, 2015 | |
| 0573-0199-21 | 00573019921 | 20 BLISTER PACK in 1 CARTON (0573-0199-21) / 1 TABLET, COATED in 1 BLISTER PACKMarketed from Jul 1, 2015 | |
| 0573-0199-22 | 00573019922 | 30 BLISTER PACK in 1 CARTON (0573-0199-22) / 1 TABLET, COATED in 1 BLISTER PACKMarketed from Nov 2, 2015 |
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 Sinus Congestion And Pain
- Generic name (nonproprietary)
- ibuprofen, phenylephrine hydrochloride
- Active ingredients
- Ibuprofen — 200 mg/1Phenylephrine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Haleon US Holdings LLC
- 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 0573-0199_3a894971-32f7-0c16-e063-6294a90aa8d9SPL ID 3a894971-32f7-0c16-e063-6294a90aa8d9SPL set ID b1e29c19-fe03-4d2b-b966-0adf4eb4b4cfRxCUI 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
N400573019901followed by a unit qualifier and the quantityPackage 00573-0199-01. 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.
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 Pain Reliefibuprofen, phenylephrine hydrochloride | Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1 | Tablet, CoatedOral | Navajo Manufacturing Company Inc. | 67751-150 |