Last updated: June 25, 2026
Claritin RediTabs is a brand of the antihistamine loratadine formulated as an orally disintegrating tablet/rapid-dissolve dosage form. The supplier picture is split between (1) the branded product owner and (2) contract manufacturing and packaging for finished dosage forms. The only reliable path to identify specific manufacturers is the firm named on the product’s FDA labeling (Drug Label) and the entities listed on the Orange Book for the approved NDA and strength-specific products.
No supplier list can be produced from the information provided.
Which companies supply Claritin RediTabs (loratadine) to the U.S. market?
Answer: The supplier(s) must be identified from the approved NDA’s FDA labeling and Orange Book listings for the specific dosage strength and presentation.
What supplier identifiers are used on FDA records?
Key fields that determine the “supplier” in practice:
- Applicant/holder of the approved NDA (brand owner for regulatory filings)
- Manufacturer(s) for drug product and packaging on FDA labeling
- Patent/market exclusivity status (Orange Book listings tied to the NDA)
- Labeler name and distributor on the package insert and enforcement reports
Who typically appears in Claritin RediTabs documentation?
For U.S. prescription and OTC products, the typical naming patterns are:
- NDA holder (legal manufacturer for regulatory submissions)
- Labeler/distributor shown on packaging (may differ from NDA holder)
- Contract manufacturing sites for dosage form and packaging
What is the Orange Book listing for Claritin RediTabs, and who are the NDA entities?
Answer: Orange Book listings are NDA-specific and strength/presentation-specific; they identify the labeler, applicant, and the drug substance/drug product status that links to manufacturing and listing history.
How to interpret Orange Book “drug product” and “applicant” fields
- Drug product entries map to specific strengths and dosage forms
- “Applicant” is the NDA holder entity on file
- Manufacturing information is often accessible via FDA labeling rather than patent records
What matters for supplier verification?
- Whether the entry is for tablets, ODT/RediTabs, and the same strength (e.g., 10 mg)
- Whether there are multiple listed manufacturers across strengths and package types
- Whether the product is marketed under the OTC monograph or NDA pathway (for loratadine products, “NDA vs OTC monograph” depends on the exact approved product record)
Who manufactures the finished tablets for Claritin RediTabs (contract manufacturing + packaging)?
Answer: The finished dosage-form supplier and packaging/labeling sites are determined by the manufacturer sections of FDA labeling for the exact RediTabs presentation.
Manufacturing and packaging categories that define “supplier”
- Drug product manufacturing (tablet compression, disintegration layer formation, coating if any)
- Primary packaging (blister, bottle, unit dose)
- Secondary packaging and labeling
Why “supplier” varies by distribution lot
Even within a single brand, multiple sites can be used:
- Labeling may list more than one manufacturer
- Distribution may change manufacturing sites lot-by-lot
What labels and records identify Claritin RediTabs supply-chain sources?
Answer: The FDA labeler name and the “Manufactured for”/“Distributed by” sections of the package insert and prescribing information are the fastest defensible supplier identifiers.
Which documents are the most direct?
- The “Drug Facts” / package insert for the specific RediTabs presentation
- NDA labeling PDFs hosted by FDA (or republished by the NDA holder)
- Orange Book entry for the NDA (for applicant mapping)
When do supplier changes occur for Claritin RediTabs?
Answer: Supplier changes typically occur via CMC supplement approvals or manufacturing site changes that update labeling and sometimes Orange Book manufacturing descriptors.
Timing patterns seen in NDA/CMC changes
- Prior to a new packaging format or site transfer
- After facility updates or inspections
- After supplement approval reflecting manufacturing responsibility shifts
Key Takeaways
- A credible supplier list for Claritin RediTabs requires FDA-labeling manufacturer and labeler entries tied to the specific RediTabs presentation.
- Orange Book identifies NDA entities and exclusivity-linked entries, but manufacturing and packaging suppliers are validated in the product’s FDA labeling.
- Without the specific FDA record(s) for Claritin RediTabs (NDA number and presentation), a complete supplier list cannot be produced.
FAQs
- How can I identify the contract manufacturer for Claritin RediTabs from FDA labeling?
- Does the Claritin RediTabs NDA list multiple drug product manufacturers?
- What packaging suppliers (bottle vs blister) are used for Claritin RediTabs?
- Are Claritin RediTabs suppliers different from other loratadine Claritin formats (liquigels, tablets)?
- How do Orange Book entries link to Claritin RediTabs applicant and distributor entities?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA Drug Label / Drug Facts for Claritin RediTabs (loratadine) specific presentation. U.S. Food and Drug Administration.
