Fexofenadine HCl and Pseudoephedrine HCI NDC 43598-823

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-823Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0823Add 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
43598-823-14	43598082314	4 BLISTER PACK in 1 CARTON (43598-823-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 18, 2019
43598-823-31	43598082331	6 BLISTER PACK in 1 CARTON (43598-823-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 18, 2019
43598-823-35	43598082335	2 BLISTER PACK in 1 CARTON (43598-823-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 31, 2019

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): Fexofenadine HCl and Pseudoephedrine HCI
Generic name (nonproprietary): fexofenadine hcl and pseudoephedrine hci
Active ingredients: Fexofenadine hydrochloride — 60 mg/1Pseudoephedrine hydrochloride — 120 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 076667
Marketing start: Jul 18, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 43598-823_d024126e-de41-3d5e-73d8-bbb2623037e6SPL ID d024126e-de41-3d5e-73d8-bbb2623037e6SPL set ID 6fd05737-d996-b5b6-dccf-bc179a9d606cRxCUI 997406UNII 2S068B75ZU, 6V9V2RYJ8N
Pharmacologic class: Histamine-1 Receptor Antagonist; 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

N443598082314 followed by a unit qualifier and the quantity

Package 43598-0823-14. 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

Current FDA label (SPL), effective Sep 9, 2019.

Indications (excerpt from the label)

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076667

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

FDA NDC Directory listings under ANDA 076667
Product	Strength	Form · route	Labeler	Product NDC
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	CVS Pharmacy	59779-508
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Walgreens Company	0363-1606
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	HEB	37808-022
Allergy and Congestionfexofenadine hcl and pseudoephedrine hci	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Rite Aid Corporation	11822-7388
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Limited	55111-447
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	The Kroger Co.	30142-447
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	The Kroger Co.	30142-611