levocetirizine dihydrochloride
- Product NDC
- 55111-282
- 11-digit product format
- 551110282
- Labeler code
- 55111
- Product ID
- 55111-282_acb3404e-c2a4-f21f-5f5b-f0ceab355395
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Dr.Reddy's laboratories Ltd.
- Application
- ANDA090392
- Marketing category
- ANDA
- Marketing start
- 2011-02-24
- 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 |
|---|
| 55111-282-01 | levocetirizine dihydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 8 |
| 55111-282-05 | levocetirizine dihydrochloride | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 8 |
| 55111-282-18 | levocetirizine dihydrochloride | 180 in 1 BOTTLE | TABLET, COATED | 180 | | 8 |
| 55111-282-30 | levocetirizine dihydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 8 |
| 55111-282-60 | levocetirizine dihydrochloride | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 8 |
| 55111-282-78 | levocetirizine dihydrochloride | 10 in 1 CARTON | TABLET, COATED | 10 | | 8 |
| 55111-282-79 | levocetirizine dihydrochloride | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 8 |
| 55111-282-90 | levocetirizine dihydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| levocetirizine dihydrochloride | ACTIVE INGREDIENT | SOD6A38AGA | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
| levocetirizine | ACTIVE MOIETY | 6U5EA9RT2O | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-282 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] | 8 | Current NDC, Legacy NDC, 8 package rows | 20181211_c40c1bb4-25ce-90cb-b8dd-6a4c54cddd4a.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 |
|---|
| 55111-282-01 | 55111028201 | 100 TABLET, COATED in 1 BOTTLE (55111-282-01) | | 2011-02-24 | 0000-00-00 | No | No | Current |
| 55111-282-05 | 55111028205 | 500 TABLET, COATED in 1 BOTTLE (55111-282-05) | | 2011-02-24 | 0000-00-00 | No | No | Current |
| 55111-282-18 | 55111028218 | 180 TABLET, COATED in 1 BOTTLE (55111-282-18) | | 2011-02-24 | 0000-00-00 | No | No | Current |
| 55111-282-30 | 55111028230 | 30 TABLET, COATED in 1 BOTTLE (55111-282-30) | | 2011-02-24 | 0000-00-00 | No | No | Current |
| 55111-282-60 | 55111028260 | 60 TABLET, COATED in 1 BOTTLE (55111-282-60) | | 2011-02-24 | 0000-00-00 | No | No | Current |
| 55111-282-78 | 55111028278 | 10 BLISTER PACK in 1 CARTON (55111-282-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-282-79) | 10 blister pack | 2011-02-24 | 0000-00-00 | No | No | Current |
| 55111-282-79 | 55111028279 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 55111-282-90 | 55111028290 | 90 TABLET, COATED in 1 BOTTLE (55111-282-90) | | 2011-02-24 | 0000-00-00 | No | No | Current |