loratadine antihistamine

Generic: loratadine

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

loratadine 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3414
Product ID 68071-3414_2d6c6076-d7cb-e793-e063-6294a90ac3b0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076301
Listing Expiration 2026-12-31
Marketing Start 2008-10-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713414
Hyphenated Format 68071-3414

Supplemental Identifiers

RxCUI
311372
UPC
0368071341430
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
  • 1 BOTTLE in 1 CARTON (68071-3414-3) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

68071-3414-3 1 BOTTLE in 1 CARTON (68071-3414-3) / 30 TABLET in 1 BOTTLE

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": "2d6c6076-d7cb-e793-e063-6294a90ac3b0", "openfda": {"upc": ["0368071341430"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["fc63689e-e449-ca8f-e053-6394a90a54a2"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68071-3414-3)  / 30 TABLET in 1 BOTTLE", "package_ndc": "68071-3414-3", "marketing_start_date": "20230523"}], "brand_name": "Loratadine antihistamine", "product_id": "68071-3414_2d6c6076-d7cb-e793-e063-6294a90ac3b0", "dosage_form": "TABLET", "product_ndc": "68071-3414", "generic_name": "Loratadine", "labeler_name": "NuCare 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": "20261231"}