Cetirizine Hydrochloride
- Product NDC
- 60505-2633
- 11-digit product format
- 605052633
- Labeler code
- 60505
- Product ID
- 60505-2633_17fe6683-fe11-595a-7f5b-08127105a627
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA078317
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- Marketing end
- 2021-04-30
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- 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 |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-2633-1 | EA - Each | 60505-2633 | d9df8dd8-d3b7-436d-a9e8-bbf72c13db76 | 1 | 2012-07-24 |
| 60505-2633-8 | EA - Each | 60505-2633 | bbe2ef07-7034-40ff-89d6-90d414efe32c | 1 | 2012-07-24 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | 66e7c776-4ae3-43e0-ac3e-c0bf3ad98795 | 3 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | 66e7c776-4ae3-43e0-ac3e-c0bf3ad98795 | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | 66e7c776-4ae3-43e0-ac3e-c0bf3ad98795 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60505-2633-1 | 60505263301 | 100 TABLET, FILM COATED in 1 BOTTLE (60505-2633-1) | 2007-12-27 | 2021-04-30 | No | No | Current |
| 60505-2633-3 | 60505263303 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-2633-3) | 2007-12-27 | 2021-04-30 | No | No | Current |
| 60505-2633-8 | 60505263308 | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-2633-8) | 2007-12-27 | 2021-04-30 | No | No | Current |