loratadine

Generic: loratadine

Labeler: pld acquisitions llc dba avma pharma solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler pld acquisitions llc dba avma pharma solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
PLD Acquisitions LLC DBA Avma Pharma Solutions

Identifiers & Regulatory

Product NDC 63548-0753
Product ID 63548-0753_c24222bc-72ef-4c15-b7c2-9401fe5f40a6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075209
Listing Expiration 2026-12-31
Marketing Start 2018-10-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 635480753
Hyphenated Format 63548-0753

Supplemental Identifiers

RxCUI
311372
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 loratadine (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA075209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 300 TABLET in 1 BOTTLE, PLASTIC (63548-0753-0)
  • 100 TABLET in 1 BOTTLE, PLASTIC (63548-0753-1)
  • 30 TABLET in 1 BOTTLE, PLASTIC (63548-0753-3)
source: ndc

Packages (3)

63548-0753-0 300 TABLET in 1 BOTTLE, PLASTIC (63548-0753-0) 63548-0753-1 100 TABLET in 1 BOTTLE, PLASTIC (63548-0753-1) 63548-0753-3 30 TABLET in 1 BOTTLE, PLASTIC (63548-0753-3)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c24222bc-72ef-4c15-b7c2-9401fe5f40a6", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["2edb53f8-7661-4e54-bb50-e03078bae3bf"], "manufacturer_name": ["PLD Acquisitions LLC DBA Avma Pharma Solutions"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET in 1 BOTTLE, PLASTIC (63548-0753-0)", "package_ndc": "63548-0753-0", "marketing_start_date": "20181030"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (63548-0753-1)", "package_ndc": "63548-0753-1", "marketing_start_date": "20181030"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (63548-0753-3)", "package_ndc": "63548-0753-3", "marketing_start_date": "20181030"}], "brand_name": "Loratadine", "product_id": "63548-0753_c24222bc-72ef-4c15-b7c2-9401fe5f40a6", "dosage_form": "TABLET", "product_ndc": "63548-0753", "generic_name": "Loratadine", "labeler_name": "PLD Acquisitions LLC DBA Avma Pharma Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA075209", "marketing_category": "ANDA", "marketing_start_date": "20181030", "listing_expiration_date": "20261231"}