Childrens
- Product NDC
- 68016-106
- 11-digit product format
- 680160106
- Labeler code
- 68016
- Product ID
- 68016-106_51b02412-ebbd-4045-8af4-4b8b8e90daf4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Pharmacy Value Alliance LLC
- Application
- ANDA201546
- Marketing category
- ANDA
- Marketing start
- 2011-05-20
- 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
- Brand name suffix
- Cetirzine
- 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 |
|---|
| 68016-106-08 | Childrens Cetirzine | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 68016-106-08 | Childrens Cetirzine | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-106 | CHILDRENS CETIRZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [PHARMACY VALUE ALLIANCE LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20170613_6b22f568-7ebd-4479-b764-6e5481d8c15a.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 |
|---|
| 68016-106-08 | 68016010608 | 1 BOTTLE in 1 CARTON (68016-106-08) / 118 mL in 1 BOTTLE | 1 bottle | 2011-05-20 | 0000-00-00 | No | No | Current |