Levocetirizine Dihydrochloride
- Product NDC
- 51672-4161
- 11-digit product format
- 516724161
- Labeler code
- 51672
- Product ID
- 51672-4161_2e256952-b11b-490a-9773-6f523a5b286a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine dihydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Taro Pharmaceuticals U.S.A., inc.
- Application
- ANDA202673
- Marketing category
- ANDA
- Marketing start
- 2013-07-26
- Marketing end
- 0000-00-00
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Levocetirizine dihydrochloride | ACTIVE INGREDIENT | SOD6A38AGA | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| Levocetirizine | ACTIVE MOIETY | 6U5EA9RT2O | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| acetic acid | INACTIVE INGREDIENT | Q40Q9N063P | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| maltitol | INACTIVE INGREDIENT | D65DG142WK | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| sodium acetate anhydrous | INACTIVE INGREDIENT | NVG71ZZ7P0 | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-4161 | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 13 | Legacy NDC | 20200827_df2a19c7-f437-425c-8253-a2523122a653.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-4161-1 | 51672416101 | 1 BOTTLE in 1 CARTON (51672-4161-1) > 237 mL in 1 BOTTLE | 1 bottle | 2013-07-26 | 0000-00-00 | No | No | Current |
| 51672-4161-4 | 51672416104 | 1 BOTTLE in 1 CARTON (51672-4161-4) > 59 mL in 1 BOTTLE | 1 bottle | 2013-07-26 | 0000-00-00 | No | No | Current |
| 51672-4161-5 | 51672416105 | 1 BOTTLE in 1 CARTON (51672-4161-5) > 177 mL in 1 BOTTLE | 1 bottle | 2013-07-26 | 0000-00-00 | No | No | Current |
| 51672-4161-8 | 51672416108 | 1 BOTTLE in 1 CARTON (51672-4161-8) > 118 mL in 1 BOTTLE | 1 bottle | 2013-07-26 | 0000-00-00 | No | No | Current |