Over-the-counter drug · ANDA

childrens cetirizine hydrochloride (Cetirizine hcl) NDC 0904-6765

Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6765Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6765Add 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
0904-6765-2000904676520009046765201 BOTTLE in 1 CARTON (0904-6765-20) / 118 mL in 1 BOTTLEMarketed from Aug 22, 2018

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)
childrens cetirizine hydrochloride
Generic name (nonproprietary)
cetirizine hcl
Active ingredients
Cetirizine hydrochloride — 5 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204226
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0904-6765_5f4ad745-20b6-4ed5-81aa-448c658d57c2SPL ID 5f4ad745-20b6-4ed5-81aa-448c658d57c2SPL set ID db297aa4-4384-48f2-b2bd-c842efc8a844RxCUI 1014673UNII 64O047KTOA
Pharmacologic class
Histamine-1 Receptor Antagonist

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

N400904676520 followed by a unit qualifier and the quantity

Package 00904-6765-20. 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 .

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6765

What is NDC 0904-6765?
0904-6765 is the product NDC for childrens cetirizine hydrochloride, Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
childrens cetirizine hydrochloride (Cetirizine HCl).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for childrens cetirizine hydrochloride?
9 other product NDCs are listed under this name. See all childrens cetirizine hydrochloride 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 childrens cetirizine hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Childrens Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Orally disintegratingOralWALMART INC.79903-40679903-0406-10
Childrens Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralSun Pharmaceutical Industries, Inc.51672-214751672-2147-0151672-2147-08
childrens cetirizine hydrochloridecetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralPreferred Pharmaceuticals Inc.68788-818868788-8188-01
Childrens Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Orally disintegratingOralCVS Pharmacy, Inc.69842-96169842-0961-76
Childrens Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Orally disintegratingOralWALGREEN CO.0363-402500363-4025-76
Childrens Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Orally disintegratingOralAurohealth LLC58602-85658602-0856-1458602-0856-7558602-0856-76
childrens cetirizine hydrochloridecetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-676517856-6765-0117856-6765-0317856-6765-09
childrens cetirizine hydrochloridecetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralProficient Rx LP71205-72271205-0722-04
Childrens Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralChain Drug Consortium, LLC (Premier Value)68016-02368016-0023-43

Other NDCs under ANDA 204226

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

FDA NDC Directory listings under ANDA 204226
ProductStrengthForm · routeLabelerProduct NDC
allergy relief childrenscetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralCVS Pharmacy59779-837
Basic Care Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmazon.com Services LLC72288-330
basic care childrens all day allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmazon.com Services LLC72288-475
careone childrens allergy reliefcetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmerican Sales Company41520-301
careone childrens allergy reliefcetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmerican Sales Company41520-902
Childrens 24 Hour Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralMeijer Distribution Inc41250-189
Childrens 24 Hour Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralMeijer Distribution Inc41250-475
childrens all day allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralKroger Company30142-189
Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralKroger Company30142-475
Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralHyVee Inc42507-203
childrens all day allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralHyVee Inc42507-475
Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmazon.com Services LLC72288-818
Childrens All Day Allergycetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralAmazon.com Services LLC72288-982
childrens allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralWalgreen Company0363-3311
childrens allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralWalgreen Company0363-3393
childrens allergy reliefcetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralRite Aid Corporation11822-0475
childrens allergy reliefcetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralRite Aid Corporation11822-1189
childrens allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralSafeway21130-465
childrens allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralSafeway21130-653
Childrens Allergy Reliefcetirizine hclCetirizine hydrochloride 5 mg/5mLSolutionOralCVS Pharmacy59779-509

Showing 20 of 39.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in