NDC codes

FDA NDC Directory
Product NDC (as listed)85786-203Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85786-0203Add 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
85786-203-30857860203308578602033030 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

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

N485786020330 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under ANDA 076047
ProductStrengthForm · routeLabelerProduct NDC
Cetirizine HClcetirizineCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralGERI-CARE PHARMACEUTICAL CORP57896-992
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-458
Cetirizine HydrochlorideCetirizine hydrochloride 5 mg/1TabletOralFirst Nation Group, LLC81469-352
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralFirst Nation Group, LLC81469-353
Cetirizine Hydrochloride 10 mgCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralContract Pharmacal Corp.10267-3579

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