allergy

Generic: loratadine

Labeler: selder, s.a. de c.v.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allergy
Generic Name loratadine
Labeler selder, s.a. de c.v.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Selder, S.A. de C.V.

Identifiers & Regulatory

Product NDC 63654-309
Product ID 63654-309_39201d37-e750-420b-8035-feb97bc77c21
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076471
Listing Expiration 2026-12-31
Marketing Start 2014-12-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63654309
Hyphenated Format 63654-309

Supplemental Identifiers

RxCUI
311372
UPC
0645981000269
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 allergy (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076471 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (63654-309-10) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

63654-309-10 1 BLISTER PACK in 1 CARTON (63654-309-10) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39201d37-e750-420b-8035-feb97bc77c21", "openfda": {"upc": ["0645981000269"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251"], "manufacturer_name": ["Selder, S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63654-309-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "63654-309-10", "marketing_start_date": "20141216"}], "brand_name": "Allergy", "product_id": "63654-309_39201d37-e750-420b-8035-feb97bc77c21", "dosage_form": "TABLET", "product_ndc": "63654-309", "generic_name": "Loratadine", "labeler_name": "Selder, S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076471", "marketing_category": "ANDA", "marketing_start_date": "20141216", "listing_expiration_date": "20261231"}