Guaifenesin and Pseudoephedrine HCl NDC 70677-1263

NDC codes

FDA NDC Directory

Product NDC (as listed)70677-1263Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70677-1263Add 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
70677-1263-1	70677126301	1 BLISTER PACK in 1 CARTON (70677-1263-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 13, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Strategic Sourcing Services LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212542
Marketing start: Dec 13, 2024
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 70677-1263_27f84be6-4c43-19eb-e063-6394a90a368cSPL ID 27f84be6-4c43-19eb-e063-6394a90a368cSPL set ID 27f85134-cd38-b33c-e063-6394a90a05a8RxCUI 1305603UNII 495W7451VQ, 6V9V2RYJ8N
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

N470677126301 followed by a unit qualifier and the quantity

Package 70677-1263-01. 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

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