loratadine

Generic: loratadine

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7511
Product ID 0904-7511_9f222415-3471-459d-9401-6c73d09b0f4d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076301
Listing Expiration 2027-12-31
Marketing Start 2025-03-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047511
Hyphenated Format 0904-7511

Supplemental Identifiers

RxCUI
311372
UNII
7AJO3BO7QN

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 ANDA076301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7511-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7511-61 100 BLISTER PACK in 1 CARTON (0904-7511-61) / 1 TABLET in 1 BLISTER PACK

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": "9f222415-3471-459d-9401-6c73d09b0f4d", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["60162446-4fa1-4ee3-ae20-19fadc2491ab"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7511-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7511-61", "marketing_start_date": "20250318"}], "brand_name": "Loratadine", "product_id": "0904-7511_9f222415-3471-459d-9401-6c73d09b0f4d", "dosage_form": "TABLET", "product_ndc": "0904-7511", "generic_name": "Loratadine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076301", "marketing_category": "ANDA", "marketing_start_date": "20250318", "listing_expiration_date": "20271231"}