levocetirizine dihydrochloride
- Product NDC
- 42543-712
- 11-digit product format
- 425430712
- Labeler code
- 42543
- Product ID
- 42543-712_e0dc4ba0-8ea1-47c3-8bed-427969ca5c15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Vensun Pharmaceuticals, Inc.
- 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 |
|---|
| 42543-712-03 | levocetirizine dihydrochloride | 300 in 1 BOTTLE | TABLET | 300 | | 10 |
| 42543-712-30 | levocetirizine dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 10 |
| 42543-712-90 | levocetirizine dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| levocetirizine dihydrochloride | ACTIVE INGREDIENT | SOD6A38AGA | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
| levocetirizine | ACTIVE MOIETY | 6U5EA9RT2O | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42543-712 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20180723_7a2ca8aa-ba0b-45b4-bdb3-651879350130.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 |
|---|
| 42543-712-03 | 42543071203 | 300 TABLET in 1 BOTTLE (42543-712-03) | 300 tablet | 2014-10-27 | 0000-00-00 | No | No | Current |
| 42543-712-30 | 42543071230 | 30 TABLET in 1 BOTTLE (42543-712-30) | 30 tablet | 2014-10-27 | 0000-00-00 | No | No | Current |
| 42543-712-90 | 42543071290 | 90 TABLET in 1 BOTTLE (42543-712-90) | 90 tablet | 2014-10-27 | 0000-00-00 | No | No | Current |