Levocetirizine Dihydrochloride
- Product NDC
- 31722-551
- 11-digit product format
- 317220551
- Labeler code
- 31722
- Product ID
- 31722-551_40ccc1d7-149b-e682-e063-6394a90a1d37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA091264
- Marketing category
- ANDA
- Marketing start
- 2012-06-29
- 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 |
|---|
| 31722-551-05 | Levocetirizine Dihydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
| 31722-551-10 | Levocetirizine Dihydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
| 31722-551-18 | Levocetirizine Dihydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 8 |
| 31722-551-30 | Levocetirizine Dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 31722-551-90 | Levocetirizine Dihydrochloride | 90 in 1 BOTTLE | TABLET | 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 [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| LEVOCETIRIZINE | ACTIVE MOIETY | 6U5EA9RT2O | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-551 | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 5 package rows | 20250110_dd407f8f-140d-489f-b8c5-f6602d87e247.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 |
|---|
| 31722-551-05 | 31722055105 | 500 TABLET in 1 BOTTLE (31722-551-05) | 500 tablet | 2012-06-29 | 0000-00-00 | No | No | Current |
| 31722-551-10 | 31722055110 | 1000 TABLET in 1 BOTTLE (31722-551-10) | 1000 tablet | 2012-06-29 | 0000-00-00 | No | No | Current |
| 31722-551-18 | 31722055118 | 180 TABLET in 1 BOTTLE (31722-551-18) | 180 tablet | 2012-06-29 | 0000-00-00 | No | No | Current |
| 31722-551-30 | 31722055130 | 30 TABLET in 1 BOTTLE (31722-551-30) | 30 tablet | 2012-06-29 | 0000-00-00 | No | No | Current |
| 31722-551-90 | 31722055190 | 90 TABLET in 1 BOTTLE (31722-551-90) | 90 tablet | 2012-06-29 | 0000-00-00 | No | No | Current |