loratadine and pseudoephedrine

Generic: loratadine and pseudoephedrine

Labeler: ohm laboratories inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine and pseudoephedrine
Generic Name loratadine and pseudoephedrine
Labeler ohm laboratories inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

loratadine 10 mg/1, pseudoephedrine sulfate 240 mg/1

Manufacturer
Ohm Laboratories Inc.

Identifiers & Regulatory

Product NDC 51660-491
Product ID 51660-491_39f4d9f5-7448-2a58-e063-6394a90a44b1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076557
Listing Expiration 2026-12-31
Marketing Start 2004-11-17

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51660491
Hyphenated Format 51660-491

Supplemental Identifiers

RxCUI
1117562
UNII
7AJO3BO7QN Y9DL7QPE6B

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 and pseudoephedrine (source: ndc)
Generic Name loratadine and pseudoephedrine (source: ndc)
Application Number ANDA076557 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 240 mg/1
source: ndc
Packaging
  • 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51660-491-69)
source: ndc

Packages (1)

51660-491-69 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51660-491-69)

Ingredients (2)

loratadine (10 mg/1) pseudoephedrine sulfate (240 mg/1)

Linked Drug Pages (1)

Loratadine and Pseudoephedrine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39f4d9f5-7448-2a58-e063-6394a90a44b1", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562"], "spl_set_id": ["bbe83464-a582-469f-8fac-f98e804d96fe"], "manufacturer_name": ["Ohm Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51660-491-69)", "package_ndc": "51660-491-69", "marketing_start_date": "20200115"}], "brand_name": "Loratadine and Pseudoephedrine", "product_id": "51660-491_39f4d9f5-7448-2a58-e063-6394a90a44b1", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "51660-491", "generic_name": "loratadine and pseudoephedrine", "labeler_name": "Ohm Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine and Pseudoephedrine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "240 mg/1"}], "application_number": "ANDA076557", "marketing_category": "ANDA", "marketing_start_date": "20041117", "listing_expiration_date": "20261231"}