Cetirizine Hydrochloride
- Product NDC
- 52549-2106
- 11-digit product format
- 525492106
- Labeler code
- 52549
- Product ID
- 52549-2106_5ce3ebe2-4297-4a70-b32f-cdd74c462e49
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Taro Pharmaceutical Industries, Ltd.
- Application
- ANDA201546
- Marketing category
- ANDA
- Marketing start
- 2011-05-20
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 52549-2106-1 | Cetirizine Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 52549-2106-1 | Cetirizine Hydrochloride | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 1 |
| 52549-2106-8 | Cetirizine Hydrochloride | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 1 |
| 52549-2106-8 | Cetirizine Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cetirizine Hydrochloride | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| acetic acid | INACTIVE INGREDIENT | Q40Q9N063P | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| sodium acetate anhydrous | INACTIVE INGREDIENT | NVG71ZZ7P0 | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52549-2106 | CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICAL INDUSTRIES, LTD.] | 1 | Legacy NDC, 4 package rows | 20110719_490e395b-bd03-49f1-9abc-2f060138d321.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 52549-2106-1 | 52549210601 | 1 in 1 CARTON | | Historical |
| 52549-2106-8 | 52549210608 | 118 mL in 1 BOTTLE | 118 ml | Historical |