childrens cetirizine hydrochloride
- Product NDC
- 68788-8188
- 11-digit product format
- 687888188
- Labeler code
- 68788
- Product ID
- 68788-8188_3f863e4e-e559-49e4-a298-49b5dc134d1b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA204226
- Marketing category
- ANDA
- Marketing start
- 2022-05-13
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- childrens cetirizine hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-8188-1 | childrens cetirizine hydrochloride | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 5 |
| 68788-8188-1 | childrens cetirizine hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8188 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) SOLUTION [PREFERRED PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250224_9e168299-5ba1-451a-8c85-3fbe34c36cb0.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 |
|---|
| 68788-8188-1 | 68788818801 | 1 BOTTLE in 1 CARTON (68788-8188-1) / 118 mL in 1 BOTTLE | 1 bottle | 2022-05-13 | 0000-00-00 | No | No | Current |