Pharbinex-pe Tablet, Coated
NDC Package 73057-389-04
Package Information
Pharbinex-pe (guaifenesin 400mg and phenylephrine hcl 10mg) tablets is take with a full glass of waterthis product can be administered without regard for the timing of the mealsdo not exceed 6 doses in 24 hours or as directed by a doctoradults and children 12 years of age and overtake 1 caplet every 4 hours as neededchildren 6 to under 12 years of agetake ½ caplet every 4 hours as neededchildren under 6 years of ageask a doctor. This formulation utilizes a tablet, coated delivery system. Marketed by Ulai Health Llc, this product is identified by NDC 73057-389 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1304111 - guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet
- RxCUI: 1304111 - guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 73057 - Ulai Health Llc
- 73057-389 - Pharbinex-pe
- 73057-389-04 - 30 TABLET, COATED in 1 BOTTLE, PLASTIC
- 73057-389 - Pharbinex-pe
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 73057-389-04 identifies a specific commercial package of 30 tablet, coated in 1 bottle, plastic of Pharbinex-pe, a human over the counter drug labeled by Ulai Health Llc. This tablet, coated is formulated for oral use and contains guaifenesin; phenylephrine 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 Ulai Health Llc on July 18, 2019. The current certification is valid through December 31, 2026.
How is this Ulai Health Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 73057038904. 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 Product segment to maintain the 5-4-2 structure.