childrens loratadine

Generic: loratadine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens loratadine
Generic Name loratadine
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loratadine 5 mg/5mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2073
Product ID 51672-2073_34bae067-f7a5-4be3-e063-6294a90a360f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076805
Listing Expiration 2026-12-31
Marketing Start 2004-08-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516722073
Hyphenated Format 51672-2073

Supplemental Identifiers

RxCUI
692783
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 childrens loratadine (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-2073-4) / 60 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-2073-5) / 180 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-2073-8) / 120 mL in 1 BOTTLE
source: ndc

Packages (3)

51672-2073-4 1 BOTTLE in 1 CARTON (51672-2073-4) / 60 mL in 1 BOTTLE 51672-2073-5 1 BOTTLE in 1 CARTON (51672-2073-5) / 180 mL in 1 BOTTLE 51672-2073-8 1 BOTTLE in 1 CARTON (51672-2073-8) / 120 mL in 1 BOTTLE

Ingredients (1)

loratadine (5 mg/5mL)

Linked Drug Pages (1)

Childrens Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34bae067-f7a5-4be3-e063-6294a90a360f", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["692783"], "spl_set_id": ["78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2073-4)  / 60 mL in 1 BOTTLE", "package_ndc": "51672-2073-4", "marketing_start_date": "20040820"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2073-5)  / 180 mL in 1 BOTTLE", "package_ndc": "51672-2073-5", "marketing_start_date": "20040820"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2073-8)  / 120 mL in 1 BOTTLE", "package_ndc": "51672-2073-8", "marketing_start_date": "20040820"}], "brand_name": "Childrens Loratadine", "product_id": "51672-2073_34bae067-f7a5-4be3-e063-6294a90a360f", "dosage_form": "SOLUTION", "product_ndc": "51672-2073", "generic_name": "Loratadine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "ANDA076805", "marketing_category": "ANDA", "marketing_start_date": "20040820", "listing_expiration_date": "20261231"}