Over-the-counter drug · ANDA
Childrens Allergy Relief (Cetirizine hydrochloride) NDC 55315-354
Cetirizine hydrochloride 1 mg/mL · Solution · Oral · Fred's, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55315-354-31 | 5531503543155315035431 | 1 BOTTLE in 1 CARTON (55315-354-31) / 120 mL in 1 BOTTLEMarketed from Jan 31, 2015 |
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)
- Childrens Allergy Relief
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Fred's, Inc.NDC labeler code 55315
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090750
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55315-354_17d2db07-4de0-4e02-8e2e-0082c275faabSPL ID 17d2db07-4de0-4e02-8e2e-0082c275faabSPL set ID 55e799b2-e325-4286-aa9a-b88e99ab1146RxCUI 1014673UNII 64O047KTOAUPC 0084579127580
- 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
N455315035431followed by a unit qualifier and the quantityPackage 55315-0354-31. 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 55315-354
- What is NDC 55315-354?
- 55315-354 is the product NDC for Childrens Allergy Relief (cetirizine hydrochloride), Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by Fred's, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Allergy Relief (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Fred's, Inc., NDC labeler code 55315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Allergy Relief?
- 43 other product NDCs are listed under this name. See all Childrens Allergy Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Allergy Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-533 | 72288-0533-34 |
| Childrens Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | WALMART INC. | 79903-411 | 79903-0411-0479903-0411-08 |
| childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-818 | 51316-0818-08 |
| Childrens Allergy Reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-611 | 51316-0611-34 |
| childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Safeway | 21130-607 | 21130-0607-08 |
| Childrens Allergy Relief | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Allegiant Health | 69168-471 | 69168-0471-59 |
| Childrens Allergy Reliefdiphenhydramine hcl | Diphenhydramine HCl 12.5 mg/5mL | SolutionOral | Best Choice | 63941-505 | 63941-0505-26 |
| Childrens Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Cardinal Health 110, LLC. DBA Leader | 70000-0701 | 70000-0701-01 |
| childrens allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Safeway | 21130-465 | 21130-0465-34 |
| Childrens Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Walgreen Company | 0363-4023 | 00363-4023-08 |
Other NDCs under ANDA 090750
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 |
|---|---|---|---|---|
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-422 |
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | C.D.M.A., Inc. | 63868-865 |
| Childrens Cetirizine Hydrochloride Allergycetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-028 |
| Childrens Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-030 |
| Childrens Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-036 |