Orally Disintegrating Tablets: A Spec and RFQ Sheet for Buyers

Place the tablet on your tongue, let it dissolve and swallow it with saliva. MedlinePlus (revised 15 September 2026) gives the handling for ondansetron ODTs: remove the tablet just before your dose, use dry hands, peel the foil back instead of pushing the tablet through it, and place the tablet on top of your tongue, where it dissolves in a few seconds. Follow your product's label, because each medicine has its own instructions. Questions about swallowing a tablet whole belong with a pharmacist.

An orally disintegrating tablet is, in FDA's definition, "a solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue." FDA's Orally Disintegrating Tablets guidance (December 2008, final) adds numbers to that definition.

• Disintegration time. FDA recommends an in vitro disintegration time of approximately 30 seconds or less, measured by the United States Pharmacopeia (USP) disintegration method or by an alternative shown to correlate with it. FDA's survey of applications found times from a few seconds to longer than a minute, with a large majority at approximately 30 seconds or less.
• Tablet weight. FDA generally recommends no more than 500 mg. A heavier ODT must justify that it still performs as one.
• No liquid. Tablets that take longer than 30 seconds, or that are dosed with liquids, "may be more appropriately considered to be chewable or oral tablets."

FDA states that 30 seconds is not an arbitrary line between an ODT and another tablet. It is a representative period for products that work without chewing or liquid. Our recommendation: set the target well under 30 seconds, so normal batch variation does not push lots over it.

Ondansetron, olanzapine and loratadine have the most US ODT listings in the FDA National Drug Code (NDC) directory: 202 of 526 as of 24 October 2026, and 12 molecules account for 80% of listings.

We queried the directory through openFDA for the dosage form "TABLET, ORALLY DISINTEGRATING" on 24 October 2026, when the data were last updated 23 October 2026. That returned 604 listings. We kept finished products marketed under an abbreviated new drug application (ANDA, the generic route), a new drug application (NDA), an authorized generic or a biologics license application. That left 526 listings from 132 labelers (a labeler is the company that lists the product in the NDC directory), covering 31 distinct active-ingredient combinations.

These 12 molecules total 422 listings, which is 80%, and the top three are 38%.

We publish this page, and we are not a labeler in the data. The count is a snapshot of one directory. A listing is a product entry, not a measure of sales or volume.

Most ODT listings include a blister pack, but a third include a bottle. In the same 526 listings, we marked a product as blister if any of its package descriptions contained the word BLISTER, and as bottle if any contained the word BOTTLE. Products can carry several package descriptions, so the categories overlap. The "includes" rows count every product with that word. The "only" rows count products whose package descriptions all fall in that one category.

The rows reconcile as follows. Blister-only (296) plus both (72) is 368; the other 12 blister listings also carry another package type, such as a carton. Bottle-only (95) plus both (72) is 167; the other 7 bottle listings likewise combine with another package type. Those 482 products with a blister or a bottle, plus the 44 with neither, make 526.

The pattern varies by molecule. All 47 loratadine listings are blister-only. Ondansetron splits into 33 blister-only, 27 bottle-only and 38 other combinations, meaning listings that are neither blister-only nor bottle-only (both formats, or another package type such as a carton). Olanzapine splits into 26 blister-only, 23 bottle-only and 8 other, defined the same way.

The directory records package format, not what protects the tablet inside a bottle. A 2026 review by FDA Office of Generic Drugs authors (Bagde et al., AAPS Open 2026) notes that ODTs are more fragile and moisture-sensitive, which is why blister packs are common. Our recommendation: if you plan a bottle, require stability data in that exact pack, and treat a blister as the default you must justify leaving.

An ODT is taken as its own label directs; for ondansetron, the tablet dissolves on the tongue and is swallowed with saliva. For a developer, the water instruction sets the bioequivalence (BE) design: for generics, the study follows the reference product's labeled instruction.

FDA's ondansetron product-specific guidance (a document recommending how to study bioequivalence for one drug; draft, August 2026) recommends a fasting, single-dose, two-period crossover study on the 8 mg strength, with the tablet "swallowed without water." The 4 mg strength can be waived using comparative dissolution on 12 units per strength plus a proportionally similar formulation.

This is not a trivial point. M13A is FDA's guidance on bioequivalence studies for immediate-release solid oral products. FDA reviewers checked 39 ODT products approved before M13A and found that 17 product-specific guidances recommended a different water instruction from the product label. Those guidances were then updated (Bagde et al., AAPS Open 2026).

In the one example the review gives, water changed absorption timing: for alprazolam 0.5 mg, peak time was 1.75 hours for the conventional tablet, 2 hours for the ODT with water and 2.25 hours without, while peak concentration and total exposure were bioequivalent (Bagde et al., AAPS Open 2026). The authors consider the difference unlikely to matter clinically.

Put these lines in the brief and test each against the pass criterion. The benchmarks come from the FDA guidance, the ondansetron guidance and the AAPS Open review above. The pass criteria on stability, fragility and formulation are our recommendations.

Two terms in the table need explaining. Section 505(j) of the Federal Food, Drug, and Cosmetic Act is the generic (ANDA) approval route. A suitability petition asks FDA for permission to file an ANDA for a product that differs from the reference drug, for example an ODT version of a conventional tablet.

We are a Haridwar-based pharmaceutical company, and our relevant work for an ODT buyer is API supply by quotation and oral dosage-form CDMO services (contract development and manufacturing), from product development through commercial manufacturing. ODT-specific formulation capability is assessed at the feasibility review stage; contact us with your target product.

Eleven of the 31 active ingredients in the listings appear on our pharmaceutical API list: olanzapine (57 listings), lamotrigine (40), rizatriptan benzoate (30), lansoprazole (24), omeprazole (18), mirtazapine (18), clozapine (16), aripiprazole (14), zolmitriptan (14), cetirizine hydrochloride (13) and donepezil (4). Together they cover 248 of the 526 listings, 47%: 57+40+30+24+18+18+16 = 203 for the seven molecules in the table above, plus 14+14+13+4 = 45 for the other four, and 248/526 = 47%. This is our match, October 2026: a listing counts when its active ingredient name, including salt form, matches an entry on our list (for example donepezil hydrochloride and Donepezil HCl). We matched on active ingredient, not product name. Mannitol, a common ODT filler, is on the list too.

Appearing on the list is not a stock or price promise. We quote each product individually once you give the API name and CAS number (the Chemical Abstracts Service registry number).

A quote request should include the product or CAS number, quantity, destination, grade or purity, documents needed, payment terms and Incoterms (shipping terms). For qualified B2B buyers we support sample and evaluation quantities, confirmed product by product, with the certificate of analysis (COA), specifications and safety data sheet (SDS/MSDS) where applicable. Our buying route runs from inquiry through feasibility review, commercial quotation, development or technical transfer, production and quality control, packaging and dispatch. For how contract work is vetted and quoted, see our third-party manufacturing guide.

To start, send the specification table above, filled in for your product, to sunil@aarisepharma.com or WhatsApp +91 9899783330, or use our contact form.