Levocetirizine Dihydrochloride
- Product NDC
- 10135-639
- 11-digit product format
- 101350639
- Labeler code
- 10135
- Product ID
- 10135-639_f380ef7e-eece-412d-b50c-deae2f6098d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine Dihydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA202046
- Marketing category
- ANDA
- Marketing start
- 2018-09-01
- 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 |
|---|
| 10135-639-30 | Levocetirizine Dihydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 10135-639-90 | Levocetirizine Dihydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-639 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20180901_f5d8d6a6-6455-430b-8923-090e1ca2ae3b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10135-639-30 | 10135063930 | 30 TABLET, FILM COATED in 1 BOTTLE (10135-639-30) | 2018-09-01 | 0000-00-00 | No | No | Current |
| 10135-639-90 | 10135063990 | 90 TABLET, FILM COATED in 1 BOTTLE (10135-639-90) | 2018-09-01 | 0000-00-00 | No | No | Current |