Over-the-counter drug · ANDA
Members Mark Childrens Cetirizine (Cetirizine hydrochloride) NDC 68196-475
Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Sam's West Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-475-43 | 6819604754368196047543 | 2 BOTTLE in 1 CARTON (68196-475-43) / 240 mL in 1 BOTTLE (68196-475-34)Marketed from Sep 23, 2024 |
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)
- Members Mark Childrens Cetirizine
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Sam's West IncNDC labeler code 68196
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204226
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68196-475_c1765b31-cc97-4f6e-bb57-d90f16b73a15SPL ID c1765b31-cc97-4f6e-bb57-d90f16b73a15SPL set ID 9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7dRxCUI 1014673UNII 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
N468196047543followed by a unit qualifier and the quantityPackage 68196-0475-43. 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 68196-475
- What is NDC 68196-475?
- 68196-475 is the product NDC for Members Mark Childrens Cetirizine, Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Sam's West Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Members Mark Childrens Cetirizine (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Sam's West Inc, NDC labeler code 68196. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Members Mark Childrens Cetirizine?
- 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 204226
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 |
|---|---|---|---|---|
| Good Neighbor Pharmacy Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amerisource Bergen | 46122-203 |
| childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Kroger Company | 30142-189 |
| Good Sense Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-7068 |
| childrens allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Walgreen Company | 0363-3393 |
| childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Rite Aid Corporation | 11822-0475 |
| up and up childrens allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Target Corporation | 82442-475 |
| Basic Care Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-330 |
| Equaline childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-475 |
| Topcare Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Topco Associates LLC | 36800-189 |
| Kirkland Signature Childrens Aller Teccetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Costco Wholesale Company | 63981-475 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-982 |
| Good Sense Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | L. Perrigo Company | 0113-0189 |
| foster and thrive childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Strategic Sourcing Services LLC | 70677-1042 |
| Childrens 24 Hour Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Meijer Distribution Inc | 41250-475 |
| Childrens Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | CVS Pharmacy | 59779-509 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8188 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Kroger Company | 30142-475 |
| basic care childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-475 |
| Welby Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Aldi Inc | 64024-475 |
| childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Rite Aid Corporation | 11822-1189 |
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