Xyzal
- Product NDC
- 41167-5804
- 11-digit product format
- 411675804
- Labeler code
- 41167
- Product ID
- 41167-5804_87a83f00-5abf-437d-af13-394c22964050
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chattem, Inc.
- Application
- NDA022064
- Marketing category
- NDA
- Marketing start
- 2017-07-24
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- .5 mg/mL
- 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
- Xyzal
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | .5 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | SOD6A38AGA |
| Rxcui | 855168, 855170, 855172, 855174 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 36cf9111-9cc4-8f59-a74c-0c1cfbd4a760 | Product name | 7 | 20190702 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41167-5804-5 | Xyzal | 148 mL in 1 BOTTLE | SOLUTION | 148 | 2 | |
| 41167-5804-5 | Xyzal | 1 in 1 CARTON | SOLUTION | 1 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855168 | levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution | PSN | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | PSN | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855170 | XYZAL 2.5 MG in 5 mL 24HR Oral Solution | PSN | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855174 | Xyzal 5 MG 24HR Oral Tablet | PSN | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855170 | levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [Xyzal] | SBD | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855174 | levocetirizine dihydrochloride 5 MG Oral Tablet [Xyzal] | SBD | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855168 | levocetirizine dihydrochloride 0.5 MG/ML Oral Solution | SCD | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855172 | levocetirizine dihydrochloride 5 MG Oral Tablet | SCD | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855168 | levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution | SY | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855172 | levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet | SY | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855170 | Xyzal 0.5 MG/ML Oral Solution | SY | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855170 | Xyzal 2.5 MG per 5 ML 24 HR Oral Solution | SY | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
| 855174 | Xyzal 5 MG 24 HR Oral Tablet | SY | 1673f7ff-0c7c-4403-86cf-c05eb1475222 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41167-5804-5 | 41167580405 | 1 BOTTLE in 1 CARTON (41167-5804-5) / 148 mL in 1 BOTTLE | 1 bottle | 2017-07-24 | No | No | Historical |