LEVOCETIRIZINE DIHYDROCHLORIDE
- Product NDC
- 68462-346
- 11-digit product format
- 684620346
- Labeler code
- 68462
- Product ID
- 68462-346_3dc84568-462c-4fca-b235-3a84f8a4bd7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090385
- Marketing category
- ANDA
- Marketing start
- 2011-02-25
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Listing expiration
- 2027-12-31
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 |
|---|
| 68462-346-90 | LEVOCETIRIZINE DIHYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | ACTIVE INGREDIENT | SOD6A38AGA | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| LEVOCETIRIZINE | ACTIVE MOIETY | 6U5EA9RT2O | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-346 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240104_60ae7e0e-281c-40a3-a0d3-259b843ddaaa.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 |
|---|
| 68462-346-90 | 68462034690 | 90 TABLET in 1 BOTTLE (68462-346-90) | 90 tablet | 2011-02-25 | 0000-00-00 | No | No | Current |