Over-the-counter drug · ANDA
Cetirizine HCl (cetirizine) NDC 70677-1279
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Strategic Sourcing Services LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70677-1279-1 | 70677127901 | 1 BOTTLE in 1 CARTON (70677-1279-1) / 14 TABLET in 1 BOTTLEMarketed from Apr 3, 2025 | |
| 70677-1279-2 | 70677127902 | 1 BOTTLE in 1 CARTON (70677-1279-2) / 30 TABLET in 1 BOTTLEMarketed from Mar 1, 2025 | |
| 70677-1279-3 | 70677127903 | 1 BOTTLE in 1 CARTON (70677-1279-3) / 60 TABLET in 1 BOTTLEMarketed from Mar 1, 2025 | |
| 70677-1279-4 | 70677127904 | 1 BOTTLE in 1 CARTON (70677-1279-4) / 90 TABLET in 1 BOTTLEMarketed from Mar 1, 2025 | |
| 70677-1279-5 | 70677127905 | 1 BOTTLE in 1 CARTON (70677-1279-5) / 300 TABLET in 1 BOTTLEMarketed from Mar 1, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Cetirizine HCl
- Generic name (nonproprietary)
- cetirizine
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078427
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70677-1279_2e9de837-00b0-491d-a2e3-766fab46380aSPL ID 2e9de837-00b0-491d-a2e3-766fab46380aSPL set ID 65b37b00-8efc-4e04-ab97-a03e8af27d33RxCUI 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
N470677127901followed by a unit qualifier and the quantityPackage 70677-1279-01. 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)
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.
Other NDCs under ANDA 078427
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 5 mg/1 | TabletOral | GLENMARK THERAPEUTICS INC., USA | 72657-128 |
| Cetirizine HClcetirizine | Cetirizine hydrochloride 10 mg/1 | TabletOral | GLENMARK THERAPEUTICS INC., USA | 72657-129 |
| Cetirizine HClcetirizine | — | Kit | GLENMARK THERAPEUTICS INC., USA | 72657-130 |
| Cetirizine HClcetirizine | — | Kit | GLENMARK THERAPEUTICS INC., USA | 72657-131 |