Over-the-counter drug · ANDA
Allergy Relief (cetirizine hydrochloride) NDC 57344-194
Cetirizine hydrochloride 10 mg/1 · Tablet, Coated · Oral · AAA PHARMACEUTICAL, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57344-194-01 | 57344019401 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-194-01) / 14 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 1, 2018 | |
| 57344-194-14 | 57344019414 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Apr 29, 2022 | |
| 57344-194-20 | 57344019420 | 45 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-194-20)Marketed from May 28, 2025 |
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)
- Allergy Relief
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- AAA PHARMACEUTICAL, INC.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209274
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 57344-194_52e3fa47-d8fe-183e-e063-6294a90a5a75SPL ID 52e3fa47-d8fe-183e-e063-6294a90a5a75SPL set ID ac22558b-5c82-4ab9-95b8-53eedea46282RxCUI 1014678UNII 64O047KTOAUPC 0099581911768
- 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
N457344019401followed by a unit qualifier and the quantityPackage 57344-0194-01. 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)
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.
Other NDCs under ANDA 209274
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 |
|---|---|---|---|---|
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-930 |
| CABINET Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-0119 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4219 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4230 |
| Cetirizinecetiirizine | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-764 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-194 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1047 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Advanced Rx LLC | 80513-731 |
| Crcle Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-250 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strive Pharmaceuticals Inc | 70692-139 |
| Medlinecetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Medline Industries, LP | 53329-033 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Granules India Ltd | 62207-764 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Granules Pharmaceuticals Inc. | 70010-163 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | SAFEWAY | 21130-640 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Family Dollar (FAMILY WELLNESS) | 55319-962 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-197 |
| Allergy Reliefcetirizine hcl 10 mg | Cetirizine hydrochloride 10 mg/1 | TabletOral | Allegiant Health | 69168-396 |
| Curist Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Little Pharma, Inc. | 72559-003 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | RETAIL BUSINESS SERVICES,LLC. | 72476-764 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | FSA STORE INC. | 81522-194 |
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