Over-the-counter drug · ANDA
Dr Simi Cetirizine Hydrochloride 10 mg (Cetirizine hydrochloride 10 mg) NDC 85786-203
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Farmacias De Similares TX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85786-203-30 | 8578602033085786020330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85786-203-30)Marketed from Jan 1, 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)
- Dr Simi Cetirizine Hydrochloride 10 mg
- Generic name (nonproprietary)
- cetirizine hydrochloride 10 mg
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Farmacias De Similares TX LLCNDC labeler code 85786
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076047
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 85786-203_48d835d7-5c9a-0bd6-e063-6394a90a61baSPL ID 48d835d7-5c9a-0bd6-e063-6394a90a61baSPL set ID 48d835d7-5c99-0bd6-e063-6394a90a61baRxCUI 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
N485786020330followed by a unit qualifier and the quantityPackage 85786-0203-30. 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.
About NDC 85786-203
- What is NDC 85786-203?
- 85786-203 is the product NDC for Dr Simi Cetirizine Hydrochloride 10 mg, Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Farmacias De Similares TX LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dr Simi Cetirizine Hydrochloride 10 mg (Cetirizine Hydrochloride 10 mg).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Farmacias De Similares TX LLC, NDC labeler code 85786. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dr Simi Cetirizine Hydrochloride 10 mg?
- 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 076047
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cetirizine HClcetirizine | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | GERI-CARE PHARMACEUTICAL CORP | 57896-992 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-458 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | First Nation Group, LLC | 81469-352 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-353 |
| Cetirizine Hydrochloride 10 mg | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Contract Pharmacal Corp. | 10267-3579 |