Levocetirizine Dihydrochloride
- Product NDC
- 62135-917
- 11-digit product format
- 621350917
- Labeler code
- 62135
- Product ID
- 62135-917_0782ae1c-d903-d465-e063-6294a90a6676
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA204599
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- .5 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levocetirizine Dihydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOD6A38AGA |
| Rxcui | 855168 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-917-38 | Levocetirizine Dihydrochloride | 148 mL in 1 BOTTLE | SOLUTION | 148 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-917 | LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231013_b56652ad-2cf8-4ed0-bb66-0e832772c792.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62135-917-38 | 62135091738 | 148 mL in 1 BOTTLE (62135-917-38) | 148 ml | 2022-08-30 | 0000-00-00 | No | No | Current |