levocetirizine dihydrochloride
- Product NDC
- 63187-663
- 11-digit product format
- 631870663
- Labeler code
- 63187
- Product ID
- 63187-663_9dd81e5d-5ec6-41c5-b76a-c0c3488c6d7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203646
- Marketing category
- ANDA
- Marketing start
- 2014-10-27
- 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 |
|---|
| 63187-663-30 | levocetirizine dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 63187-663-60 | levocetirizine dihydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 63187-663-90 | levocetirizine dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-663 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20191203_b84ccb27-9c52-43b9-9a46-8f52a571045e.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 |
|---|
| 63187-663-30 | 63187066330 | 30 TABLET in 1 BOTTLE (63187-663-30) | 30 tablet | 2016-03-01 | 0000-00-00 | No | No | Current |
| 63187-663-60 | 63187066360 | 60 TABLET in 1 BOTTLE (63187-663-60) | 60 tablet | 2016-03-01 | 0000-00-00 | No | No | Current |
| 63187-663-90 | 63187066390 | 90 TABLET in 1 BOTTLE (63187-663-90) | 90 tablet | 2016-03-01 | 0000-00-00 | No | No | Current |