cetirizine hydrochloride
- Product NDC
- 57664-181
- 11-digit product format
- 576640181
- Labeler code
- 57664
- Product ID
- 57664-181_a0fe22f2-9063-49d4-831f-2271643b7d0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cetirizine hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Caraco Pharmaceutical Laboratories, Ltd.
- Application
- ANDA090191
- Marketing category
- ANDA
- Marketing start
- 2009-11-16
- 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
- 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 |
|---|
| 57664-181-31 | cetirizine hydrochloride | 120 mL in 1 BOTTLE, GLASS | SYRUP | 120 | | 3 |
| 57664-181-34 | cetirizine hydrochloride | 473 mL in 1 BOTTLE, GLASS | SYRUP | 473 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-181 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SYRUP [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | Legacy NDC, 2 package rows | 20091202_23f3ec1c-bbba-49ef-b7d6-0be6e9424b99.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 57664-181-31 | 57664018131 | 120 mL in 1 BOTTLE, GLASS | 120 ml | Historical |
| 57664-181-34 | 57664018134 | 473 mL in 1 BOTTLE, GLASS | 473 ml | Historical |