Over-the-counter drug · ANDA

Good Sense all day allergy (Cetirizine hydrochloride) NDC 0113-9458

Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · L. Perrigo Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0113-9458Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00113-9458Add 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
0113-9458-3900113945839001139458391 BOTTLE in 1 CARTON (0113-9458-39) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 28, 2008
0113-9458-66001139458660011394586614 BLISTER PACK in 1 CARTON (0113-9458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 16, 2008
0113-9458-7500113945875001139458751 BOTTLE in 1 CARTON (0113-9458-75) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from May 10, 2023
0113-9458-8800113945888001139458881 BOTTLE in 1 CARTON (0113-9458-88) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 27, 2023
0113-9458-9500113945895001139458951 BOTTLE in 1 CARTON (0113-9458-95) / 45 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 8, 2010

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)
Good Sense all day allergy
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
L. Perrigo CompanyNDC labeler code 0113
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 0113-9458_c93a5e52-e438-4421-bdca-1fcfdcdb9b98SPL ID c93a5e52-e438-4421-bdca-1fcfdcdb9b98SPL set ID 2a7a27ab-1b4c-40d1-98bf-e4297aa25682RxCUI 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

N400113945839 followed by a unit qualifier and the quantity

Package 00113-9458-39. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 0113-9458

What is NDC 0113-9458?
0113-9458 is the product NDC for Good Sense all day allergy (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by L. Perrigo Company. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Good Sense all day allergy (Cetirizine Hydrochloride).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Good Sense all day allergy?
4 other product NDCs are listed under this name. See all Good Sense 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 Good Sense all day allergy NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc68788-402368788-4023-0368788-4023-0668788-4023-09
Good Sense All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralL. Perrigo Company0113-098100113-0981-63
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-706450090-7064-0150090-7064-03
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-706550090-7065-0050090-7065-01

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
TopCare All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralTopco Associates LLC36800-458
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

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