dye-free childrens loratadine (51316-821)

Drug Facts

Product Profile

Brand Name dye-free childrens loratadine

Generic Name loratadine

Labeler cvs pharmacy, inc

Dosage Form TABLET, CHEWABLE

Routes

ORAL

Active Ingredients

loratadine 5 mg/1

Manufacturer

CVS PHARMACY, INC

Identifiers & Regulatory

Product NDC 51316-821

Product ID 51316-821_10b4d4f5-ef19-4272-e063-6294a90add06

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210088

Listing Expiration 2026-12-31

Marketing Start 2024-03-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316821

Hyphenated Format 51316-821

Supplemental Identifiers

RxCUI

665078

UPC

0050428256138

UNII

7AJO3BO7QN

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dye-free childrens loratadine (source: ndc)

Generic Name loratadine (source: ndc)

Application Number ANDA210088 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (51316-821-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
3 BLISTER PACK in 1 CARTON (51316-821-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

source: ndc

Packages (2)

51316-821-20 2 BLISTER PACK in 1 CARTON (51316-821-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 51316-821-30 3 BLISTER PACK in 1 CARTON (51316-821-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

loratadine (5 mg/1)

Linked Drug Pages (1)

Dye-Free Childrens Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "10b4d4f5-ef19-4272-e063-6294a90add06", "openfda": {"upc": ["0050428256138"], "unii": ["7AJO3BO7QN"], "rxcui": ["665078"], "spl_set_id": ["0b78fed4-69eb-f66f-e063-6294a90a3b89"], "manufacturer_name": ["CVS PHARMACY, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-821-20)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "51316-821-20", "marketing_start_date": "20240315"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (51316-821-30)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "51316-821-30", "marketing_start_date": "20240315"}], "brand_name": "Dye-Free Childrens Loratadine", "product_id": "51316-821_10b4d4f5-ef19-4272-e063-6294a90add06", "dosage_form": "TABLET, CHEWABLE", "product_ndc": "51316-821", "generic_name": "Loratadine", "labeler_name": "CVS PHARMACY, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dye-Free Childrens Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA210088", "marketing_category": "ANDA", "marketing_start_date": "20240315", "listing_expiration_date": "20261231"}