Guaifenesin 600 mg (guaifenesin) NDC 43598-110

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-110Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0110Add 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
43598-110-01	43598011001	5 BLISTER PACK in 1 CARTON (43598-110-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 1, 2022

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 600 mg
Generic name (nonproprietary): guaifenesin
Active ingredients: Guaifenesin — 600 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Dr. Reddy's Laboratories Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215932
Marketing start: Sep 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 43598-110_ef6a6eb4-cde7-cd56-0290-29d56beec22cSPL ID ef6a6eb4-cde7-cd56-0290-29d56beec22cSPL set ID 525fda90-134c-f038-c403-eb5ffc1fb1f1RxCUI 310621, 636522UNII 495W7451VQ
Pharmacologic class: Expectorant

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

N443598011001 followed by a unit qualifier and the quantity

Package 43598-0110-01. 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

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

Other NDCs under ANDA 215932

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

FDA NDC Directory listings under ANDA 215932
Product	Strength	Form · route	Labeler	Product NDC
Guaifenesin 1200 mgguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-009
Guaifenesin 600 mgguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-008
Guaifenesin 600 mgguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	CVS Pharmacy	51316-008
Guaifenesin 1200 mgguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-108
Guaifenesin 1200 mgguaifenesin	Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Strategic Sourcing Services, LLC	70677-1258
Guaifenesin 600 mgguaifenesin	Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Strategic Sourcing Services, LLC	70677-1257