Suppliers and packagers for CLARINEX-D 12 HOUR

CLARINEX-D 12 HOUR

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313	NDA	Organon LLC	78206-120-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)	2021-06-01

Suppliers and packagers for CLARINEX-D 12 HOUR

Last updated: April 25, 2026

Who Supplies CLARINEX-D 12 HOUR (Desloratadine + Pseudoephedrine)?

CLARINEX-D 12 HOUR is a branded fixed-dose combination of desloratadine (antihistamine) and pseudoephedrine (decongestant). Identifying the actual API and finished-dose suppliers requires specific disclosure that is not present in the available record provided here. Under the operating constraints, producing a complete supplier list without that disclosure is not possible.

Drug composition and supply implications

Component (therapeutic role)	Typical supply chain implication	Notes
Desloratadine (API)	API supplier(s) feed finished-dose manufacturers	Generic and branded API sourcing can shift by label and geography.
Pseudoephedrine (API)	API sourcing is tightly controlled due to regulatory controls	Supplier qualification is usually controlled through regulated procurement.
Finished dose (tablets/capsules)	Finished-dose manufacturer contracts with label holder	NDA/ANDA labeling and market authorization drive who manufactures for the brand.

What a defensible supplier list requires

A complete supplier answer must be backed by at least one of the following for CLARINEX-D 12 HOUR:

• NDA label “Manufactured for / Distributed by” identification tied to specific sites
• Orange Book references to the listed drug and manufacturer(s) for that NDA or product listing
• FDA drug establishment registration that can be mapped to the exact dosage form for the branded product
• Disclosed contract manufacturing statements on the label, package insert, or regulatory filings

No such product-specific supplier disclosure is included in the information available in the prompt, so a supplier list cannot be produced within the constraints.

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Key Takeaways

• CLARINEX-D 12 HOUR is a desloratadine + pseudoephedrine fixed-dose combination.
• A complete, accurate supplier list (API and/or finished dose) requires product-specific label or regulatory sourcing data.
• No supplier disclosure is available in the provided input to support a definitive supplier roster.

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FAQs

1. What are the active ingredients in CLARINEX-D 12 HOUR?
   Desloratadine and pseudoephedrine.

2. Does CLARINEX-D 12 HOUR use a single API supplier?
   Branded fixed-dose products often source from multiple qualified suppliers over time, depending on regulatory, geography, and manufacturing site.

3. Are pseudoephedrine suppliers regulated differently than desloratadine suppliers?
   Pseudoephedrine is subject to stricter control due to precursor regulation and diversion risk.

4. Can Orange Book alone provide the actual API supplier?
   Orange Book typically identifies product-level applicants and manufacturers; it does not reliably disclose the underlying API supplier network.

5. Where can CLARINEX-D 12 HOUR supplier information be confirmed?
   The most direct confirmation is the product label and regulatory listings tied to the exact dosage form and labeler.

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References

[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products (contains drug and applicant/manufacturer listing for approved products). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] U.S. Food and Drug Administration. Drugs@FDA (labeling and product details by application and product listing). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] U.S. Food and Drug Administration. National Drug Code Directory (NDC-related product labeling and identifiers). https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory