Over-the-counter drug · ANDA

TopCare All Day Allergy (Cetirizine hydrochloride) NDC 36800-458

Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-458Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0458Add 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
36800-458-3936800045839368000458391 BOTTLE in 1 CARTON (36800-458-39) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 16, 2009
36800-458-4736800045847368000458471 BOTTLE in 1 CARTON (36800-458-47) / 150 TABLET, FILM COATED in 1 BOTTLEMarketed from May 26, 2010
36800-458-66368000458663680004586614 BLISTER PACK in 1 CARTON (36800-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 10, 2008
36800-458-7236800045872368000458721 BOTTLE in 1 CARTON (36800-458-72) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 28, 2008
36800-458-7536800045875368000458751 BOTTLE in 1 CARTON (36800-458-75) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 19, 2008
36800-458-8736800045887368000458871 BOTTLE in 1 CARTON (36800-458-87) / 300 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 28, 2010
36800-458-9536800045895368000458951 BOTTLE in 1 CARTON (36800-458-95) / 45 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 8, 2009

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)
TopCare All Day Allergy
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Topco Associates LLCNDC labeler code 36800
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078336
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 36800-458_dc4e4803-536c-4a2b-9faa-e307a66eb91aSPL ID dc4e4803-536c-4a2b-9faa-e307a66eb91aSPL set ID f2919aad-9ed4-40b8-b233-4aec06df33eaRxCUI 1014678UNII 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

N436800045839 followed by a unit qualifier and the quantity

Package 36800-0458-39. 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 36800-458

What is NDC 36800-458?
36800-458 is the product NDC for TopCare All Day Allergy (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Topco Associates LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TopCare All Day Allergy (Cetirizine Hydrochloride).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TopCare All Day Allergy?
2 other product NDCs are listed under this name. See all TopCare All Day Allergy 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 TopCare All Day Allergy NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
topcare all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralTopco Associates LLC36800-44836800-0448-0936800-0448-4936800-0448-63
Topcare All Day Allergylevocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, Film coatedOralTopco Associates LLC36800-24136800-0241-0136800-0241-4636800-0241-95

Other NDCs under ANDA 078336

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

FDA NDC Directory listings under ANDA 078336
ProductStrengthForm · routeLabelerProduct NDC
Goodnow Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralGobrands, Inc82501-0422
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0194
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-123
allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSafeway21130-425
rexall all day allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDolgencorp, LLC55910-699
All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralHyVee Inc42507-458
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-862
good neighbor pharmacy all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAmerisource Bergen24385-998
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-343
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7594
equate allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-458
leader all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-0380
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPadagis Israel Pharmaceuticals Ltd45802-919
CareOne Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAmerican Sales Company41520-781
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralProficient Rx LP71205-207
Up and Up Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralTarget Corporation11673-502
Exchange select all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralArmy & Air Force Exchange Service55301-076
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7064
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7065
Members Mark Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSam's West Inc68196-413

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