loratadine

Generic: loratadine

Labeler: marksans pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler marksans pharma limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-021
Product ID 25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206214
Listing Expiration 2026-12-31
Marketing Start 2016-10-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000021
Hyphenated Format 25000-021

Supplemental Identifiers

RxCUI
828269
UPC
0325000021368 0325000021344
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 ANDA206214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08)
  • 600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13)
  • 4 BAG in 1 BOX (25000-021-21) / 7500 CAPSULE, LIQUID FILLED in 1 BAG
  • 28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34)
  • 3 BLISTER PACK in 1 CARTON (25000-021-36) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 8 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46)
source: ndc

Packages (6)

25000-021-08 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08) 25000-021-13 600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13) 25000-021-21 4 BAG in 1 BOX (25000-021-21) / 7500 CAPSULE, LIQUID FILLED in 1 BAG 25000-021-34 28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34) 25000-021-36 3 BLISTER PACK in 1 CARTON (25000-021-36) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 25000-021-46 8 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46)

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": "adf6c78c-edb1-4ffb-a934-d8cb772e621f", "openfda": {"upc": ["0325000021368", "0325000021344"], "unii": ["7AJO3BO7QN"], "rxcui": ["828269"], "spl_set_id": ["c30907f9-1761-41e5-bd4e-2613e756e1c6"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08)", "package_ndc": "25000-021-08", "marketing_start_date": "20161001"}, {"sample": false, "description": "600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13)", "package_ndc": "25000-021-13", "marketing_start_date": "20161001"}, {"sample": false, "description": "4 BAG in 1 BOX (25000-021-21)  / 7500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "25000-021-21", "marketing_start_date": "20161001"}, {"sample": false, "description": "28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34)", "package_ndc": "25000-021-34", "marketing_start_date": "20161001"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (25000-021-36)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "25000-021-36", "marketing_start_date": "20201017"}, {"sample": false, "description": "8 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46)", "package_ndc": "25000-021-46", "marketing_start_date": "20161001"}], "brand_name": "Loratadine", "product_id": "25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621f", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "25000-021", "generic_name": "Loratadine", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA206214", "marketing_category": "ANDA", "marketing_start_date": "20161001", "listing_expiration_date": "20261231"}