Cetirizine Hydrochloride
- Product NDC
- 13668-596
- 11-digit product format
- 136680596
- Labeler code
- 13668
- Product ID
- 13668-596_d6e3bd11-efa1-cbee-e053-2995a90ae5ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Torrent Pharma Inc.
- Application
- ANDA078870
- Marketing category
- ANDA
- Marketing start
- 2018-07-13
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13668-596-07 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-9e43-a426-e053-dadaa90af4c2 | a1078430-f84a-4afe-9ff2-95f6754749c3 |
| 13668-596-11 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-9e43-a426-e053-dadaa90af4c2 | a1078430-f84a-4afe-9ff2-95f6754749c3 |
| 13668-596-07 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9e43-a426-e053-dadaa90af4c2 | a1078430-f84a-4afe-9ff2-95f6754749c3 |
| 13668-596-11 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9e43-a426-e053-dadaa90af4c2 | a1078430-f84a-4afe-9ff2-95f6754749c3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13668-596-07 | ML - Milliliter | 13668-596 | 05e82206-be9b-4c33-bf9f-eb1de420baa2 | 1 | 2018-08-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | 95d73b05-1b3f-404e-be2e-5efc333748b7 | 3 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | 95d73b05-1b3f-404e-be2e-5efc333748b7 | 3 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | 95d73b05-1b3f-404e-be2e-5efc333748b7 | 3 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | 95d73b05-1b3f-404e-be2e-5efc333748b7 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 13668-596-07 | 13668059607 | 120 mL in 1 BOTTLE (13668-596-07) | 120 ml | 2018-07-13 | 0000-00-00 | No | No | Current |
| 13668-596-11 | 13668059611 | 480 mL in 1 BOTTLE (13668-596-11) | 480 ml | 2018-07-13 | 0000-00-00 | No | No | Current |