loratadine and pseudoephedrine

Generic: loratadine and pseudoephedrine

Labeler: proficient rx lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine and pseudoephedrine
Generic Name loratadine and pseudoephedrine
Labeler proficient rx lp
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-305
Product ID 63187-305_4b42b2f4-a013-4b16-bc3e-d9c3b503beed
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 63187305
Hyphenated Format 63187-305

Supplemental Identifiers

RxCUI
1117562
UNII
7AJO3BO7QN Y9DL7QPE6B

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
  • 1 BLISTER PACK in 1 CARTON (63187-305-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

63187-305-10 1 BLISTER PACK in 1 CARTON (63187-305-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "4b42b2f4-a013-4b16-bc3e-d9c3b503beed", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562"], "spl_set_id": ["ca1a6552-d082-4312-ba17-0055e8554eb9"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63187-305-10)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63187-305-10", "marketing_start_date": "20150301"}], "brand_name": "Loratadine and Pseudoephedrine", "product_id": "63187-305_4b42b2f4-a013-4b16-bc3e-d9c3b503beed", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "63187-305", "generic_name": "loratadine and pseudoephedrine", "labeler_name": "Proficient Rx LP", "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"}