What is NDC 0363-1106?

0363-1106 is the product NDC for Ibuprofen and Pseudoephedrine HCl, Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 capsule, liquid filled, listed with the FDA by WALGREEN CO.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Ibuprofen, Pseudoephedrine hydrochloride.

WALGREEN CO., 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 Ibuprofen and Pseudoephedrine HCl?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ibuprofen and Pseudoephedrine HCl NDC 0363-1106

NDC codes

FDA NDC Directory

Product NDC (as listed)0363-1106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00363-1106Add 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
0363-1106-08	00363110608	4 BLISTER PACK in 1 CARTON (0363-1106-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Dec 1, 2017
0363-1106-67	00363110667	2 BLISTER PACK in 1 CARTON (0363-1106-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Dec 1, 2017

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): Ibuprofen and Pseudoephedrine HCl
Generic name (nonproprietary): ibuprofen and pseudoephedrine hcl
Active ingredients: Ibuprofen — 200 mg/1Pseudoephedrine hydrochloride — 30 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: WALGREEN CO.NDC labeler code 0363
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209235
Marketing start: Dec 1, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 0363-1106_06d66abd-d234-4a0b-a915-354d2ae24537SPL ID 06d66abd-d234-4a0b-a915-354d2ae24537SPL set ID 1cc6e3f0-64f7-4974-a62c-5db46ca9e7c5RxCUI 1299018UNII WK2XYI10QM, 6V9V2RYJ8N
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug; 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

N400363110608 followed by a unit qualifier and the quantity

Package 00363-1106-08. 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 8, 2023.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0363-1106

What is NDC 0363-1106?: 0363-1106 is the product NDC for Ibuprofen and Pseudoephedrine HCl, Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 capsule, liquid filled, listed with the FDA by WALGREEN CO.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ibuprofen and Pseudoephedrine HCl.
What is the active ingredient?: Ibuprofen, Pseudoephedrine hydrochloride.
Who is the labeler?: WALGREEN CO., 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 Ibuprofen and Pseudoephedrine HCl?: 4 other product NDCs are listed under this name. See all Ibuprofen and Pseudoephedrine HCl 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 Ibuprofen and Pseudoephedrine HCl NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ibuprofen and Pseudoephedrine HCl	Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1	Capsule, Liquid filledOral	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0606	70000-0606-0170000-0606-02
Ibuprofen and Pseudoephedrine HCl	Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1	Capsule, Liquid filledOral	Amerisource Bergen	46122-609	46122-0609-58
Ibuprofen and Pseudoephedrine HCl	Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1	Capsule, Liquid filledOral	Aurohealth LLC	58602-803	58602-0803-0358602-0803-0858602-0803-13+1 more
Ibuprofen and Pseudoephedrine HCl	Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1	Capsule, Liquid filledOral	CVS Pharmacy, Inc.	69842-092	69842-0092-1369842-0092-67

Other NDCs under ANDA 209235

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

FDA NDC Directory listings under ANDA 209235
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen and Pseudoephedrine HCl	Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1	Capsule, Liquid filledOral	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0606
Ibuprofen and Pseudoephedrine HCl	Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1	Capsule, Liquid filledOral	Aurohealth LLC	58602-803
Ibuprofen and Pseudoephedrine HCl	Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1	Capsule, Liquid filledOral	CVS Pharmacy, Inc.	69842-092
Ibuprofen and Pseudoephedrine HCl	Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1	Capsule, Liquid filledOral	Amerisource Bergen	46122-609