Childrens Cetirizine Hydrochloride
- Product NDC
- 68016-023
- 11-digit product format
- 680160023
- Labeler code
- 68016
- Product ID
- 68016-023_c067a0f7-cadb-42cb-9bd4-6b901aec98c4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chain Drug Consortium, LLC (Premier Value)
- Application
- ANDA090182
- Marketing category
- ANDA
- Marketing start
- 2008-04-22
- 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 |
|---|
| 68016-023-43 | Childrens Cetirizine Hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 2 |
| 68016-023-43 | Childrens Cetirizine Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cetirizine Hydrochloride | ACTIVE INGREDIENT | 64O047KTOA | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| acetic acid | INACTIVE INGREDIENT | Q40Q9N063P | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| sodium acetate anhydrous | INACTIVE INGREDIENT | NVG71ZZ7P0 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-023 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)] | 2 | Current NDC, Legacy NDC, 2 package rows | 20190207_b47b0c8b-59d5-4e17-95be-a992c6861ee7.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 |
|---|
| 68016-023-43 | 68016002343 | 1 BOTTLE in 1 CARTON (68016-023-43) / 120 mL in 1 BOTTLE | 1 bottle | 2008-04-22 | 0000-00-00 | No | No | Current |