alavert allergy and congestion d-12 hour

Generic: loratadine and pseudoephedrine sulfate

Labeler: foundation consumer brands
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alavert allergy and congestion d-12 hour
Generic Name loratadine and pseudoephedrine sulfate
Labeler foundation consumer brands
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

loratadine 5 mg/1, pseudoephedrine sulfate 120 mg/1

Manufacturer
Foundation Consumer Brands

Identifiers & Regulatory

Product NDC 80070-100
Product ID 80070-100_b349557d-e1ba-435d-b0db-1cdce853b418
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076050
Listing Expiration 2026-12-31
Marketing Start 2021-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80070100
Hyphenated Format 80070-100

Supplemental Identifiers

RxCUI
1242399 1242401
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 alavert allergy and congestion d-12 hour (source: ndc)
Generic Name loratadine and pseudoephedrine sulfate (source: ndc)
Application Number ANDA076050 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (80070-100-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (80070-100-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

80070-100-12 2 BLISTER PACK in 1 CARTON (80070-100-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 80070-100-24 4 BLISTER PACK in 1 CARTON (80070-100-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

loratadine (5 mg/1) pseudoephedrine sulfate (120 mg/1)

Linked Drug Pages (1)

Alavert Allergy and Congestion D-12 hour ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b349557d-e1ba-435d-b0db-1cdce853b418", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1242399", "1242401"], "spl_set_id": ["1a669f3c-36a6-439e-843d-47638fa217e8"], "manufacturer_name": ["Foundation Consumer Brands"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (80070-100-12)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "80070-100-12", "marketing_start_date": "20211215"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (80070-100-24)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "80070-100-24", "marketing_start_date": "20211215"}], "brand_name": "Alavert Allergy and Congestion D-12 hour", "product_id": "80070-100_b349557d-e1ba-435d-b0db-1cdce853b418", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "80070-100", "generic_name": "LORATADINE and PSEUDOEPHEDRINE SULFATE", "labeler_name": "Foundation Consumer Brands", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alavert", "brand_name_suffix": "Allergy and Congestion D-12 hour", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "120 mg/1"}], "application_number": "ANDA076050", "marketing_category": "ANDA", "marketing_start_date": "20211215", "listing_expiration_date": "20261231"}