Cetirizine Hydrochloride
- Product NDC
- 53217-163
- 11-digit product format
- 532170163
- Labeler code
- 53217
- Product ID
- 53217-163_9eec1107-0de2-4d44-aba2-3d06952c7ab9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA078488
- Marketing category
- ANDA
- Marketing start
- 2013-12-03
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-163-01 | Cetirizine Hydrochloride | 480 mL in 1 BOTTLE, GLASS | SOLUTION | 480 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-163 | CETIRIZINE HYDROCHLORIDE SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20170221_2a6ce99c-8722-4100-8550-22d97754fdd3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 53217-163-01 | 53217016301 | 480 mL in 1 BOTTLE, GLASS | 480 ml | Historical |