Over-the-counter drug · ANDA
Dye Free Childrens Cetirizine Hydrocholride (Cetirizine hcl) NDC 68094-004
Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-004-62 | 6809400046268094000462 | 3 TRAY in 1 CASE (68094-004-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59)Marketed from Oct 26, 2016 |
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)
- Dye Free Childrens Cetirizine Hydrocholride
- Generic name (nonproprietary)
- cetirizine hcl
- Active ingredients
- Cetirizine hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Precision Dose, Inc.NDC labeler code 68094
- 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 68094-004_16b6f804-4056-45a4-8764-8ca4256b3b43SPL ID 16b6f804-4056-45a4-8764-8ca4256b3b43SPL set ID 6a7c4dff-66c6-4d0c-af10-d908c65a43beRxCUI 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
N468094000462followed by a unit qualifier and the quantityPackage 68094-0004-62. 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 68094-004
- What is NDC 68094-004?
- 68094-004 is the product NDC for Dye Free Childrens Cetirizine Hydrocholride, Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Precision Dose, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dye Free Childrens Cetirizine Hydrocholride (Cetirizine hcl).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Precision Dose, Inc., NDC labeler code 68094. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dye Free Childrens Cetirizine Hydrocholride?
- 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 |
|---|---|---|---|---|
| up and up childrens allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Target Corporation | 82442-475 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-818 |
| 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 | 82442-617 |
| Members Mark Childrens Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Sam's West Inc | 68196-475 |
| Good Sense Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | L. Perrigo Company | 0113-0189 |
| Good Neighbor Pharmacy Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amerisource Bergen | 46122-203 |
| Good Sense Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8803 |
| Topcare Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Topco Associates LLC | 36800-189 |
| Basic Care Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-330 |
| 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 |
| Childrens 24 Hour Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Meijer Distribution Inc | 41250-475 |
| 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 |
| Childrens Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | CVS Pharmacy | 59779-509 |
| foster and thrive childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Strategic Sourcing Services LLC | 70677-1042 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6765 |
| childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Rite Aid Corporation | 11822-1189 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | HyVee Inc | 42507-203 |
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