Guaifenesin and Pseudoephedrine HCl NDC 62207-828

NDC codes

FDA NDC Directory

Product NDC (as listed)62207-828Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62207-0828Add 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 NDC	11-digit (billing)	Package	Copy
62207-828-71	62207082871	7 BLISTER PACK in 1 CARTON (62207-828-71) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2023

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): Guaifenesin and Pseudoephedrine HCl
Generic name (nonproprietary): guaifenesin and pseudoephedrine hcl
Active ingredients: Guaifenesin — 1200 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Granules India Ltd
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216082
Marketing start: Jun 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 62207-828_44f2a33c-21a2-28a8-e063-6294a90a50abSPL ID 44f2a33c-21a2-28a8-e063-6294a90a50abSPL set ID 75f4ff44-02e7-4a23-a394-85fe8b442e1aRxCUI 1244675, 1305603UNII 6V9V2RYJ8N, 495W7451VQUPC 0362207828710, 0362207827720
Pharmacologic class: Expectorant; alpha-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

N462207082871 followed by a unit qualifier and the quantity

Package 62207-0828-71. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 216082

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

FDA NDC Directory listings under ANDA 216082
Product	Strength	Form · route	Labeler	Product NDC
Guaifenesin and Pseudoephedrine HCl	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Extended releaseOral	Granules India Ltd	62207-827