NDC codes

FDA NDC Directory
Product NDC (as listed)83745-188Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83745-0188Add 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
83745-188-04837450188041 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLEMarketed from Dec 22, 2025
83745-188-08837450188081 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLEMarketed from Apr 16, 2026
83745-188-1283745018812120 mL in 1 BOTTLE, PLASTIC (83745-188-12)Marketed from Apr 16, 2026
83745-188-16837450188161 BOTTLE in 1 CARTON (83745-188-16) / 473 mL in 1 BOTTLEMarketed from Apr 16, 2026
83745-188-2483745018824240 mL in 1 BOTTLE, PLASTIC (83745-188-24)Marketed from Apr 16, 2026
83745-188-4883745018848480 mL in 1 BOTTLE, PLASTIC (83745-188-48)Marketed from Apr 16, 2026

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)
Cetrizine Hydrochloride
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 1 mg/mL
Dosage form
Solution
Route
Oral
Labeler
APOZEAL PHARMACEUTICALS INCNDC labeler code 83745
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090474
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 83745-188_6b714ab7-ee3a-4b6a-ab4b-de3c2b2b2499SPL ID 6b714ab7-ee3a-4b6a-ab4b-de3c2b2b2499SPL set ID 9c0549cf-4c93-45d9-9eac-3948fa45554eRxCUI 1014673UNII 64O047KTOAUPC 0383745188128, 0383745188241
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

N483745018804 followed by a unit qualifier and the quantity

Package 83745-0188-04. 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 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 83745-188

What is NDC 83745-188?
83745-188 is the product NDC for Cetrizine Hydrochloride (cetirizine hydrochloride), Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by APOZEAL PHARMACEUTICALS INC. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cetrizine Hydrochloride (Cetirizine hydrochloride).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
APOZEAL PHARMACEUTICALS INC, NDC labeler code 83745. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetrizine Hydrochloride?
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.

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