Over-the-counter drug · ANDA

allergy relief d NDC 37808-651

cetirizine hydrochloride, pseudoephedrine hydrochloride · Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · H E B

NDC codes

FDA NDC Directory
Product NDC (as listed)37808-651Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0651Add 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 NDC11-digit (billing)PackageCopy
37808-651-533780806515312 BLISTER PACK in 1 CARTON (37808-651-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 24, 2021
37808-651-623780806516224 BLISTER PACK in 1 CARTON (37808-651-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 18, 2021

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, pseudoephedrine hydrochloride
Active ingredients
Cetirizine hydrochloride — 5 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
H E B
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210719
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 37808-651_c97e5860-b35b-4959-926c-d555b8622dfaSPL ID c97e5860-b35b-4959-926c-d555b8622dfaSPL set ID b3ca8aae-04f2-4c00-9fb5-ce3ed7e6f1bbRxCUI 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

N437808065153 followed by a unit qualifier and the quantity

Package 37808-0651-53. 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 .

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 the 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)

Other NDCs under ANDA 210719

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

FDA NDC Directory listings under ANDA 210719
ProductStrengthForm · routeLabelerProduct NDC
Foster And Thrive All Day Allergy Dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralStrategic Sourcing Services LLC70677-1311
12 hour allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-728
Leader Allergy Relief Dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0042
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy69842-415
signature care allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralSafeway21130-644
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-147
topcare all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-744
Cetirizine hydrochloride and Pseudoephedrine hydrochloridecetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPadagis Israel Pharmaceuticals Ltd45802-147
allergy relief D12cetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-4923
kirkland signature aller tec dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCostco Wholesale Company63981-147
equate allergy relief d nasal decongestantcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-126
all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralKroger Company30142-450
Allergy Relief D12cetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-607
good neighbor pharmacy all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralAmerisource Bergen46122-626
All Day Allergy Dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-2147
Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloridecetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralRugby Laboratories0536-1279
good sense all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0147
Allergy and Sinus Reliefcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralKroger Company30142-633
allergy relief-Dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralRite Aid Corporation11822-3009

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