levocetirizine dihydrochloride
- Product NDC
- 68391-955
- 11-digit product format
- 683910955
- Labeler code
- 68391
- Product ID
- 68391-955_6098f8c4-4502-287f-cd05-06e17d773116
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- BJWC (Berkley & Jensen / BJ'S)
- Application
- ANDA210375
- Marketing category
- ANDA
- Marketing start
- 2020-06-24
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- 5 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOD6A38AGA |
| Rxcui | 855172 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68391-955-11 | levocetirizine dihydrochloride | 2 in 1 PACKAGE | TABLET, COATED | 2 | | 3 |
| 68391-955-55 | levocetirizine dihydrochloride | 55 in 1 BOTTLE | TABLET, COATED | 55 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68391-955 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S) ] | 2 | Current NDC, 2 package rows | 20241020_0216f644-767c-ae88-f48f-cd29ac1547ed.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68391-955-11 | 68391095511 | 2 BOTTLE in 1 PACKAGE (68391-955-11) / 55 TABLET, COATED in 1 BOTTLE (68391-955-55) | 2 bottle | 2024-08-15 | No | No | Historical |
| 68391-955-55 | 68391095555 | 55 in 1 BOTTLE | | | | | Historical |