CETIRIZINE HYDROLORIDE Allergy
- Product NDC
- 57664-263
- 11-digit product format
- 576640263
- Labeler code
- 57664
- Product ID
- 57664-263_60c4d8e0-3578-4ad3-aaad-272d1c1b5afd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETIRIZINE HYDROLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Caraco Pharmaceutical Laboratories, Ltd
- Application
- ANDA091327
- Marketing category
- ANDA
- Marketing start
- 2011-12-01
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 57664-263-31 | CETIRIZINE HYDROLORIDE Allergy | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 1 |
| 57664-263-34 | CETIRIZINE HYDROLORIDE Allergy | 470 mL in 1 BOTTLE | SOLUTION | 470 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-263 | CETIRIZINE HYDROLORIDE ALLERGY (CETIRIZINE HYDROLORIDE ) SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD] | 1 | Legacy NDC, 2 package rows | 20111201_60c4d8e0-3578-4ad3-aaad-272d1c1b5afd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 57664-263-31 | 57664026331 | 120 mL in 1 BOTTLE | 120 ml | Historical |
| 57664-263-34 | 57664026334 | 470 mL in 1 BOTTLE | 470 ml | Historical |