childrens cetirizine hydrochloride
- Product NDC
- 71205-722
- 11-digit product format
- 712050722
- Labeler code
- 71205
- Product ID
- 71205-722_8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA204226
- Marketing category
- ANDA
- Marketing start
- 2018-08-22
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- childrens cetirizine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-722-04 | childrens cetirizine hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 71205-722-04 | childrens cetirizine hydrochloride | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-722 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) SOLUTION [PROFICIENT RX LP] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221118_8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-722-04 | 71205072204 | 1 BOTTLE in 1 CARTON (71205-722-04) / 118 mL in 1 BOTTLE | 1 bottle | 2022-11-17 | 0000-00-00 | No | No | Current |