loratadine and pseudoephedrine sulfate (49035-488)

Drug Facts

Product Profile

Brand Name loratadine and pseudoephedrine sulfate

Generic Name loratadine and pseudoephedrine sulfate

Labeler wal-mart stores, inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

WAL-MART STORES, INC

Identifiers & Regulatory

Product NDC 49035-488

Product ID 49035-488_32b910db-c0a5-104e-e063-6294a90a3012

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA076557

Listing Expiration 2026-12-31

Marketing Start 2020-06-15

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49035488

Hyphenated Format 49035-488

Supplemental Identifiers

RxCUI

1117562

UPC

0681131366311

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 sulfate (source: ndc)

Generic Name loratadine and pseudoephedrine sulfate (source: ndc)

Application Number ANDA076557 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
240 mg/1

source: ndc

Packaging

15 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-15)
10 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-69)

source: ndc

Packages (2)

49035-488-15 15 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-15) 49035-488-69 10 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-69)

Ingredients (2)

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

Linked Drug Pages (1)

Loratadine and Pseudoephedrine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "32b910db-c0a5-104e-e063-6294a90a3012", "openfda": {"upc": ["0681131366311"], "unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562"], "spl_set_id": ["59453133-20bf-4f13-855a-b47b22302d8b"], "manufacturer_name": ["WAL-MART STORES, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-15)", "package_ndc": "49035-488-15", "marketing_start_date": "20200615"}, {"sample": false, "description": "10 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-69)", "package_ndc": "49035-488-69", "marketing_start_date": "20200615"}], "brand_name": "Loratadine and Pseudoephedrine Sulfate", "product_id": "49035-488_32b910db-c0a5-104e-e063-6294a90a3012", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "49035-488", "generic_name": "Loratadine and Pseudoephedrine Sulfate", "labeler_name": "WAL-MART STORES, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine and Pseudoephedrine Sulfate", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "240 mg/1"}], "application_number": "ANDA076557", "marketing_category": "ANDA", "marketing_start_date": "20200615", "listing_expiration_date": "20261231"}