CETIRIZINE HYDROCHLORIDE
- Product NDC
- 12634-987
- 11-digit product format
- 126340987
- Labeler code
- 12634
- Product ID
- 12634-987_4ff5ce14-77ce-4757-a40e-e7099f15a011
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETIRIZINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA076677
- Marketing category
- ANDA
- Marketing start
- 2010-01-01
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|---|---|---|---|---|
| 12634-987-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3004-f424-e053-dadaa90a57ce | Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS |
| 12634-987-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3004-f424-e053-dadaa90a57ce | Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS |
| 12634-987-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3004-f424-e053-dadaa90a57ce | Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS |
| 12634-987-71 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3004-f424-e053-dadaa90a57ce | Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS |
| 12634-987-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3004-f424-e053-dadaa90a57ce | Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS |
| 12634-987-96 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3004-f424-e053-dadaa90a57ce | Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS |
| 12634-987-97 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3004-f424-e053-dadaa90a57ce | Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12634-987-00 | CETIRIZINE HYDROCHLORIDE | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | 2 | |
| 12634-987-01 | CETIRIZINE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 2 | |
| 12634-987-50 | CETIRIZINE HYDROCHLORIDE | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 2 | |
| 12634-987-71 | CETIRIZINE HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 2 | |
| 12634-987-80 | CETIRIZINE HYDROCHLORIDE | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | 2 | |
| 12634-987-96 | CETIRIZINE HYDROCHLORIDE | 6 in 1 BOTTLE, PLASTIC | TABLET | 6 | 2 | |
| 12634-987-97 | CETIRIZINE HYDROCHLORIDE | 7 in 1 BOTTLE, PLASTIC | TABLET | 7 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 12634-987-71 | EA - Each | 12634-987 | 820f0d0e-bbef-4ee2-b5ae-c9b55277facc | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.] | 2 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.] | 2 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f | 2 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f | 2 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 12634-987-00 | 12634098700 | 10 in 1 BOTTLE, PLASTIC | Historical |
| 12634-987-01 | 12634098701 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 12634-987-50 | 12634098750 | 50 in 1 BOTTLE, PLASTIC | Historical |
| 12634-987-71 | 12634098771 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 12634-987-80 | 12634098780 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 12634-987-96 | 12634098796 | 6 in 1 BOTTLE, PLASTIC | Historical |
| 12634-987-97 | 12634098797 | 7 in 1 BOTTLE, PLASTIC | Historical |