What is NDC 58602-028?

58602-028 is the product NDC for Childrens Cetirizine Hydrochloride Allergy, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by Aurohealth LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Childrens Cetirizine Hydrochloride Allergy (Cetirizine Hydrochloride).

Aurohealth LLC, NDC labeler code 58602. 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 Allergy?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 58602-028

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-028Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0028Add 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
58602-028-20	5860200282058602002820	1 BOTTLE in 1 CARTON (58602-028-20) / 240 mL in 1 BOTTLEMarketed from Jun 24, 2015
58602-028-24	5860200282458602002824	1 BOTTLE in 1 CARTON (58602-028-24) / 120 mL in 1 BOTTLEMarketed from Jun 24, 2015
58602-028-26	5860200282658602002826	480 mL in 1 BOTTLE (58602-028-26)Marketed from Jun 24, 2015

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): Childrens Cetirizine Hydrochloride Allergy
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Aurohealth LLCNDC labeler code 58602
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090750
Marketing start: Jun 24, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 58602-028_8e40b28c-df9f-4bd3-85f5-2e191c1169ceSPL ID 8e40b28c-df9f-4bd3-85f5-2e191c1169ce
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

N458602002820 followed by a unit qualifier and the quantity

Package 58602-0028-20. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 58602-028

What is NDC 58602-028?: 58602-028 is the product NDC for Childrens Cetirizine Hydrochloride Allergy, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by Aurohealth LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Childrens Cetirizine Hydrochloride Allergy (Cetirizine Hydrochloride).
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: Aurohealth LLC, NDC labeler code 58602. 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 Allergy?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 090750

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

FDA NDC Directory listings under ANDA 090750
Product	Strength	Form · route	Labeler	Product NDC
Childrens Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Fred's, Inc.	55315-354
Childrens Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Aurohealth LLC	58602-422
Childrens Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	C.D.M.A., Inc.	63868-865
Childrens Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Aurohealth LLC	58602-030
Childrens Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Aurohealth LLC	58602-036

Childrens Cetirizine Hydrochloride Allergy (Cetirizine hydrochloride) NDC 58602-028