Over-the-counter drug · ANDA
Cetrizine Hydrochloride (cetirizine hydrochloride) NDC 83745-188
Cetirizine hydrochloride 1 mg/mL · Solution · Oral · APOZEAL PHARMACEUTICALS INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83745-188-04 | 83745018804 | 1 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLEMarketed from Dec 22, 2025 | |
| 83745-188-08 | 83745018808 | 1 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLEMarketed from Apr 16, 2026 | |
| 83745-188-12 | 83745018812 | 120 mL in 1 BOTTLE, PLASTIC (83745-188-12)Marketed from Apr 16, 2026 | |
| 83745-188-16 | 83745018816 | 1 BOTTLE in 1 CARTON (83745-188-16) / 473 mL in 1 BOTTLEMarketed from Apr 16, 2026 | |
| 83745-188-24 | 83745018824 | 240 mL in 1 BOTTLE, PLASTIC (83745-188-24)Marketed from Apr 16, 2026 | |
| 83745-188-48 | 83745018848 | 480 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 INC
- 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
N483745018804followed by a unit qualifier and the quantityPackage 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.