What is NDC 0363-1606?

0363-1606 is the product NDC for Fexofenadine HCl and Pseudoephedrine HCI, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Walgreens Company. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Fexofenadine hydrochloride, Pseudoephedrine hydrochloride.

Walgreens Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fexofenadine HCl and Pseudoephedrine HCI?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fexofenadine HCl and Pseudoephedrine HCI NDC 0363-1606

NDC codes

FDA NDC Directory

Product NDC (as listed)0363-1606Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00363-1606Add 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
0363-1606-20	0036316062000363160620	4 BLISTER PACK in 1 CARTON (0363-1606-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 16, 2019
0363-1606-30	0036316063000363160630	6 BLISTER PACK in 1 CARTON (0363-1606-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 16, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Walgreens CompanyNDC labeler code 0363
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076667
Marketing start: Sep 16, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0363-1606_22a37aee-5811-616b-a794-4c24bd940d73SPL ID 22a37aee-5811-616b-a794-4c24bd940d73SPL set ID 37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b3RxCUI 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

N400363160620 followed by a unit qualifier and the quantity

Package 00363-1606-20. 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 Aug 4, 2015.

Indications (excerpt from the label)

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itchy, watery eyes itching of the nose or throat 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)

About NDC 0363-1606

What is NDC 0363-1606?: 0363-1606 is the product NDC for Fexofenadine HCl and Pseudoephedrine HCI, Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Walgreens Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fexofenadine HCl and Pseudoephedrine HCI.
What is the active ingredient?: Fexofenadine hydrochloride, Pseudoephedrine hydrochloride.
Who is the labeler?: Walgreens Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fexofenadine HCl and Pseudoephedrine HCI?: 7 other product NDCs are listed under this name. See all Fexofenadine HCl and Pseudoephedrine HCI NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fexofenadine HCl and Pseudoephedrine HCI NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-823	43598-0823-1443598-0823-3143598-0823-35
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	The Kroger Co.	30142-611	30142-0611-14
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	HEB	37808-022	37808-0022-31
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	The Kroger Co.	30142-447	30142-0447-14
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	CVS Pharmacy	59779-508	59779-0508-1459779-0508-31
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	55111-0447-1455111-0447-3155111-0447-35
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1	Tablet, Extended releaseOral	Dr.Reddy's Laboratories Limited	55111-557	55111-0557-0755111-0557-2955111-0557-35

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
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	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
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	HEB	37808-022
Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Inc.	43598-823
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	CVS Pharmacy	59779-508