Childrens Cetirizine Hydrochloride
- Product NDC
- 71205-705
- 11-digit product format
- 712050705
- Labeler code
- 71205
- Product ID
- 71205-705_582db483-394e-4c00-8522-4041a11696e4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090182
- Marketing category
- ANDA
- Marketing start
- 2011-09-08
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71205-705_582db483-394e-4c00-8522-4041a11696e4
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- Childrens Cetirizine Hydrochloride
- Brand name suffix
- Sugar Free Grape
- Generic name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Marketing start
- 2011-09-08
- Marketing category
- ANDA
- Application number
- ANDA090182
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 1 mg/mL |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014673 |
| Spl Set Id | 582db483-394e-4c00-8522-4041a11696e4 |
| Manufacturer Name | Proficient Rx LP |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 64O047KTOA | CETIRIZINE HYDROCHLORIDE | 83881-52-1 | CETIRIZINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-705-72 | 71205070572 | 1 BOTTLE in 1 CARTON (71205-705-72) / 120 mL in 1 BOTTLE | 1 bottle | 2022-10-13 | 0000-00-00 | No | No | Current |