Cetirizine Hydrochloride
- Product NDC
- 51991-837
- 11-digit product format
- 519910837
- Labeler code
- 51991
- Product ID
- 51991-837_f5f83019-f264-4675-a36b-72090e28b9a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA078488
- Marketing category
- ANDA
- Marketing start
- 2013-12-03
- Marketing end
- 2024-11-30
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51991-837-04 | ML - Milliliter | 51991-837 | c1388144-60ad-4239-a110-e7b1692d7159 | 1 | 2014-02-04 |
| 51991-837-16 | ML - Milliliter | 51991-837 | 4db4fdf9-93e9-475a-ac39-2c656adeb70f | 1 | 2014-02-04 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | b6c435bb-0a4f-422d-814d-a95db5404e87 | 2 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | b6c435bb-0a4f-422d-814d-a95db5404e87 | 2 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | b6c435bb-0a4f-422d-814d-a95db5404e87 | 2 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | b6c435bb-0a4f-422d-814d-a95db5404e87 | 2 |
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | 2a6ce99c-8722-4100-8550-22d97754fdd3 | 1 |
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | fbea1782-20c3-45ea-bf01-4edf86d12752 | 1 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | 2a6ce99c-8722-4100-8550-22d97754fdd3 | 1 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | fbea1782-20c3-45ea-bf01-4edf86d12752 | 1 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | 2a6ce99c-8722-4100-8550-22d97754fdd3 | 1 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | fbea1782-20c3-45ea-bf01-4edf86d12752 | 1 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | 2a6ce99c-8722-4100-8550-22d97754fdd3 | 1 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | fbea1782-20c3-45ea-bf01-4edf86d12752 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51991-837-04 | 51991083704 | 120 mL in 1 BOTTLE (51991-837-04) | 120 ml | 2013-12-03 | 0000-00-00 | No | No | Current |
| 51991-837-16 | 51991083716 | 480 mL in 1 BOTTLE (51991-837-16) | 480 ml | 2013-12-03 | 0000-00-00 | No | No | Current |