What is NDC 68016-531?

68016-531 is the product NDC for Allergy relief-D, Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by CHAIN DRUG CONSORTIUM,LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Allergy relief-D (Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride).

What is the active ingredient?

Cetirizine hydrochloride, Pseudoephedrine hydrochloride.

CHAIN DRUG CONSORTIUM,LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Allergy relief-D?

14 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Allergy relief-D NDC 68016-531 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68016-531Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68016-0531Add 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
68016-531-24	6801605312468016053124	24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (68016-531-24)Marketed from Aug 17, 2016

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): Allergy relief-D
Generic name (nonproprietary): cetirizine hydrochloride and pseudoephedrine hydrochloride
Active ingredients: Cetirizine hydrochloride — 5 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: CHAIN DRUG CONSORTIUM,LLCNDC labeler code 68016
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090922
Marketing start: Aug 17, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68016-531_d2448d3f-a6f0-47c9-bf63-0a4bcdaf0ae4SPL ID d2448d3f-a6f0-47c9-bf63-0a4bcdaf0ae4SPL set ID 0f5de86d-1c87-4664-83f6-4c17f78f7d35RxCUI 1014571UNII 64O047KTOA, 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

N468016053124 followed by a unit qualifier and the quantity

Package 68016-0531-24. 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 Nov 30, 2018.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of nose or throat nasal congestion 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 68016-531

What is NDC 68016-531?: 68016-531 is the product NDC for Allergy relief-D, Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by CHAIN DRUG CONSORTIUM,LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Allergy relief-D (Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride).
What is the active ingredient?: Cetirizine hydrochloride, Pseudoephedrine hydrochloride.
Who is the labeler?: CHAIN DRUG CONSORTIUM,LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Allergy relief-D?: 14 other product NDCs are listed under this name. See all Allergy relief-D 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 Allergy relief-D NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Allergy Relief-Dloratadine and pseudoephedrine sulfate	Pseudoephedrine sulfate 240 mg/1; Loratadine 10 mg/1	Tablet, Extended releaseOral	HEB	37808-787	37808-0787-0737808-0787-35
Allergy Relief Dloratadine, pseudoephedrine sulfate	Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1	Tablet, Extended releaseOral	Walgreen Company	0363-2010	00363-2010-22
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	STRATEGIC SOURCING SERVICES LLC	70677-1020	70677-1020-0170677-1020-02
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	RITE AID	11822-9994	11822-9994-0111822-9994-02
allergy relief-Dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Rite Aid Corporation	11822-3009	11822-3009-00
Allergy Relief Dchlorpheniramine maleate, pseudoephedrine hcl	Chlorpheniramine maleate 4 mg/1; Pseudoephedrine hydrochloride 60 mg/1	TabletOral	Walgreen Company	0363-1110	00363-1110-22
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	H E B	37808-651	37808-0651-5337808-0651-62
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	CVS Pharmacy	69842-415	69842-0415-5369842-0415-62
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Publix Super Markets Inc	56062-147	56062-0147-5356062-0147-62
Allergy Relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	CVS PHARMACY	69842-994	69842-0994-1269842-0994-24

All 15 Allergy relief-D NDCs

Other NDCs under ANDA 090922

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

FDA NDC Directory listings under ANDA 090922
Product	Strength	Form · route	Labeler	Product NDC
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	STRATEGIC SOURCING SERVICES LLC	70677-1020
Wal-Zyr Dcetirizine hydrochloride and pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Walgreen Company	0363-0989
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	RITE AID	11822-9994
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Ohm Laboratories Inc.	51660-940
Allergy Relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	CVS PHARMACY	69842-994
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	62756-915