childrens cetirizine hydrochloride
- Product NDC
- 17856-6765
- 11-digit product format
- 178566765
- Labeler code
- 17856
- Product ID
- 17856-6765_50c2baa2-d912-32d0-e063-6394a90a01da
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- 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
- 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 |
|---|
| 17856-6765-1 | childrens cetirizine hydrochloride | 72 in 1 BOX, UNIT-DOSE | SOLUTION | 72 | | 2 |
| 17856-6765-2 | childrens cetirizine hydrochloride | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 2 |
| 17856-6765-3 | childrens cetirizine hydrochloride | 120 in 1 CASE | SOLUTION | 120 | | 2 |
| 17856-6765-3 | childrens cetirizine hydrochloride | 2.5 mL in 1 SYRINGE | SOLUTION | 2.5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-6765 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 1 | Current NDC, 4 package rows | 20241215_cb47e536-8eed-4a32-b9c2-e8535fb93886.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 17856-6765-1 | 17856676501 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6765-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-6765-2) | | 2024-12-12 | No | No | Historical |
| 17856-6765-2 | 17856676502 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 17856-6765-3 | 17856676503 | 120 SYRINGE in 1 CASE (17856-6765-3) / 2.5 mL in 1 SYRINGE | 120 syringe | 2026-04-30 | No | No | Historical |