Cetirizine Hydrochloride
- Product NDC
- 15127-909
- 11-digit product format
- 151270909
- Labeler code
- 15127
- Product ID
- 15127-909_f37b9fdc-9610-429f-bed4-d74893eda296
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Select Brand
- Application
- ANDA077498
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 15127-909-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0acb-f424-e053-dadaa90a57ce | Drug Facts |
| 15127-909-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0acb-f424-e053-dadaa90a57ce | Drug Facts |
| 15127-909-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0acb-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15127-909-14 | Cetirizine Hydrochloride | 14 in 1 BLISTER PACK | TABLET | 14 | 1 | |
| 15127-909-30 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 15127-909-90 | Cetirizine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CETIRIZINE HYDROCHLORIDE TABLET [SELECT BRAND] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | a6f55152-a88d-4894-9756-758dbde6e7d2 | 1 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | a6f55152-a88d-4894-9756-758dbde6e7d2 | 1 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | a6f55152-a88d-4894-9756-758dbde6e7d2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 15127-909-14 | 15127090914 | 14 in 1 BLISTER PACK | Historical |
| 15127-909-30 | 15127090930 | 30 in 1 BOTTLE | Historical |
| 15127-909-90 | 15127090990 | 90 in 1 BOTTLE | Historical |