loratadine antihistamine

Generic: loratadine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine antihistamine
Generic Name loratadine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-347
Product ID 72789-347_4bbdaf19-94a0-bf42-e063-6294a90ae5ec
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076301
Listing Expiration 2027-12-31
Marketing Start 2008-10-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789347
Hyphenated Format 72789-347

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 antihistamine (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
  • 14 TABLET in 1 BOTTLE, PLASTIC (72789-347-14)
  • 20 TABLET in 1 BOTTLE, PLASTIC (72789-347-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-347-30)
  • 300 TABLET in 1 BOTTLE, PLASTIC (72789-347-87)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-347-90)
source: ndc

Packages (5)

72789-347-14 14 TABLET in 1 BOTTLE, PLASTIC (72789-347-14) 72789-347-20 20 TABLET in 1 BOTTLE, PLASTIC (72789-347-20) 72789-347-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-347-30) 72789-347-87 300 TABLET in 1 BOTTLE, PLASTIC (72789-347-87) 72789-347-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-347-90)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine antihistamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4bbdaf19-94a0-bf42-e063-6294a90ae5ec", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["039f144b-891b-4ab0-e063-6394a90aa4c8"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (72789-347-14)", "package_ndc": "72789-347-14", "marketing_start_date": "20251218"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (72789-347-20)", "package_ndc": "72789-347-20", "marketing_start_date": "20240516"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-347-30)", "package_ndc": "72789-347-30", "marketing_start_date": "20230823"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE, PLASTIC (72789-347-87)", "package_ndc": "72789-347-87", "marketing_start_date": "20230823"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-347-90)", "package_ndc": "72789-347-90", "marketing_start_date": "20230823"}], "brand_name": "Loratadine antihistamine", "product_id": "72789-347_4bbdaf19-94a0-bf42-e063-6294a90ae5ec", "dosage_form": "TABLET", "product_ndc": "72789-347", "generic_name": "Loratadine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "brand_name_suffix": "antihistamine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076301", "marketing_category": "ANDA", "marketing_start_date": "20081015", "listing_expiration_date": "20271231"}