ALLEROFF
- Product NDC
- 16853-1307
- 11-digit product format
- 168531307
- Labeler code
- 16853
- Product ID
- 16853-1307_bdd5bed7-9c23-4457-87ab-cfefadfc97bb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Corporacion Infarmasa
- Application
- NDA019835
- Marketing category
- NDA
- 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
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 16853-1307-2 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bd18-621f-e053-dbdaa90a74ad | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16853-1307-1 | ALLEROFF | 000000000010 in 1 BLISTER PACK | TABLET | 000000000010 | 3 | |
| 16853-1307-2 | ALLEROFF | 00000000000003 in 1 BOX | TABLET | 00000000000003 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA] | 3 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 16853-1307 | ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA] | 3 | Legacy NDC, 2 package rows | 20100603_f0c7c9c6-4c48-4a93-9f94-750aed3ccd85.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1020025 | Alleroff 10 MG Oral Tablet | PSN | f0c7c9c6-4c48-4a93-9f94-750aed3ccd85 | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | f0c7c9c6-4c48-4a93-9f94-750aed3ccd85 | 3 |
| 1020025 | cetirizine hydrochloride 10 MG Oral Tablet [Alleroff] | SBD | f0c7c9c6-4c48-4a93-9f94-750aed3ccd85 | 3 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | f0c7c9c6-4c48-4a93-9f94-750aed3ccd85 | 3 |
| 1020025 | Alleroff (cetirizine dihydrochloride 10 MG) Oral Tablet | SY | f0c7c9c6-4c48-4a93-9f94-750aed3ccd85 | 3 |
| 1020025 | Alleroff 10 MG Oral Tablet | SY | f0c7c9c6-4c48-4a93-9f94-750aed3ccd85 | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | f0c7c9c6-4c48-4a93-9f94-750aed3ccd85 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 16853-1307-1 | 16853130701 | 000000000010 in 1 BLISTER PACK | Historical |
| 16853-1307-2 | 16853130702 | 00000000000003 in 1 BOX | Historical |