clarinex-d 12 hour

Generic: desloratadine and pseudoephedrine sulfate

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarinex-d 12 hour
Generic Name desloratadine and pseudoephedrine sulfate
Labeler organon llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

desloratadine 2.5 mg/1, pseudoephedrine sulfate 120 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-120
Product ID 78206-120_64c0d4d8-2434-45c4-801e-710026c5b07f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021313
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Established (EPC)
histamine-1 receptor antagonist [epc]
Mechanism of Action
histamine h1 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206120
Hyphenated Format 78206-120

Supplemental Identifiers

RxCUI
1112248 1112250
UNII
FVF865388R Y9DL7QPE6B
NUI
N0000000190 N0000175587

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 clarinex-d 12 hour (source: ndc)
Generic Name desloratadine and pseudoephedrine sulfate (source: ndc)
Application Number NDA021313 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)
source: ndc

Packages (1)

78206-120-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)

Ingredients (2)

desloratadine (2.5 mg/1) pseudoephedrine sulfate (120 mg/1)

Linked Drug Pages (1)

CLARINEX-D 12 HOUR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "64c0d4d8-2434-45c4-801e-710026c5b07f", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["FVF865388R", "Y9DL7QPE6B"], "rxcui": ["1112248", "1112250"], "spl_set_id": ["1af66b7a-4ab8-40d8-abdd-22d3310228a8"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)", "package_ndc": "78206-120-01", "marketing_start_date": "20210601"}], "brand_name": "CLARINEX-D 12 HOUR", "product_id": "78206-120_64c0d4d8-2434-45c4-801e-710026c5b07f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "78206-120", "generic_name": "desloratadine and pseudoephedrine sulfate", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLARINEX-D 12 HOUR", "active_ingredients": [{"name": "DESLORATADINE", "strength": "2.5 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "120 mg/1"}], "application_number": "NDA021313", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}