Advil Cold And Sinus Tablet, Coated
NDC Package 0573-2160-74
Package Information
Advil Cold And Sinus (ibuprofen and pseudoephedrine hydrochloride) tablets is do not take more than directedthe smallest effective dose should be usedadults and children 12 years of age and over:take 1 caplet every 4 to 6 hours while symptoms persist. This formulation utilizes a tablet, coated delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0573-2160 and is authorized under FDA application NDA019771.
Identification & Billing
- RxCUI: 1299021 - ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral Tablet
- RxCUI: 1299021 - ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
Clinical Specifications
- Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 0573 - Haleon Us Holdings Llc
- 0573-2160 - Advil Cold And Sinus
- 0573-2160-74 - 2 CARTON in 1 PACKAGE / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK
- 0573-2160 - Advil Cold And Sinus
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0573-2160-74 identifies a specific commercial package of 2 carton in 1 package / 4 blister pack in 1 carton / 10 tablet, coated in 1 blister pack of Advil Cold And Sinus, a human over the counter drug labeled by Haleon Us Holdings Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This tablet, coated is formulated for oral use and contains ibuprofen; pseudoephedrine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Haleon Us Holdings Llc on January 01, 2018. The current certification is valid through December 31, 2026.
How is this Haleon Us Holdings Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00573216074. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.