Compressed tablets as a solid oral dosage form · Size and shape limits for swallowing, 22 mm largest dimension, code imprints required in the US, scoring and split-tablet criteria, weight variation, disintegration and dissolution controls, coating and hardness range
A pharmaceutical tablet is a solid oral dosage form made by compressing a blend of active pharmaceutical ingredient (API) and excipients — fillers, binders, disintegrants and lubricants — into a defined shape and size, which may then be film-, sugar- or enteric-coated. When tablets are made by a contract manufacturer or bought as a finished product, ask three things first: what strength, release type and patient group the tablet serves, what size, shape, coating, imprint and scoring the market and its regulator expect, and which in-process and release tests the batch must pass.
Finished compressed tablets for human medicines — immediate- and modified-release, coated and uncoated, scored and unscored — as a product specified for development, contract manufacture or supply. Tablet presses and their tooling (see tablet press punch tip and feed frame), coating machines (see tablet coating machine), counting and bottling lines, excipients and APIs as raw materials, chewable, orally disintegrating and effervescent tablets and dietary supplements are outside this page except where compared.
01
FDA's guidance on size, shape and other physical attributes of generic tablets and capsules (Revision 1, October 2022) recommends that the largest dimension of a tablet should not exceed 22 mm. For generics of a reference listed drug (RLD) under 17 mm in largest dimension, it recommends no more than 20% larger in any single dimension (and not over 17 mm) and no more than 40% larger in volume; for an RLD of 17 mm or more, no larger in any dimension or in volume, with more flexibility for products of 8 mm or smaller. It cites studies in which 8 mm round tablets passed the oesophagus faster than 11 mm round and 14 × 9 mm oval tablets. [1]
The same guidance recommends a shape similar to the reference or easier to swallow, using the largest cross-sectional area as one measure, and notes that the lack of a film coating can reduce tablet mobility compared with a coated tablet of the same size and shape, that heavier tablets transit faster than lighter ones of similar size, and that surface area, disintegration time and swelling also matter. [1]
Under 21 CFR 206.10, no solid oral dosage form drug product may enter US interstate commerce unless it carries a code imprint that, with its size, shape and colour, uniquely identifies the product (active ingredients and strength) and its manufacturer or distributor; imprints may be embossed, debossed, engraved or printed in ink, and letters or numbers are encouraged over a symbol alone. Products that do not comply may be considered adulterated and misbranded. [3]
Editorial calculation: for a reference tablet 10 mm round, the guidance allows a generic up to 12 mm in diameter (10 × 1.2) and 40% more volume; for a 15 mm reference, 20% larger would be 18 mm, so the 17 mm ceiling applies instead. [1]
Give the manufacturer the strength and release type, target market and patient group, reference product dimensions if a generic, preferred shape and maximum size, coating type and colour, imprint or debossing artwork, scoring, packaging and the regulatory dossier format required.
02
FDA's guidance on tablet scoring (March 2013) asks that split portions of a scored tablet meet the same finished-product tests as a whole tablet of equivalent strength. For immediate-release tablets it calls for weight variation testing of split portions where they contain 25 mg or more of a drug that is 25% or more of the portion's weight (otherwise content uniformity), splitability shown at both ends of the hardness range by testing 15 tablets for a loss of mass under 3.0% between the segments, split portions meeting USP friability, dissolution meeting release requirements, and 90-day stability of split tablets at 25 ± 2 °C / 60 ± 5% RH in pharmacy containers. Modified-release products whose release control could be compromised by splitting should not be scored. [2]
21 CFR 211.110 requires written in-process controls to assure batch uniformity and integrity, including where appropriate tablet weight variation, disintegration time, adequacy of mixing, dissolution time and rate and bioburden testing, with in-process specifications consistent with final product specifications and derived from process averages and variability where possible. [4]
Ask the manufacturer for the release specification (assay, uniformity of dosage units, dissolution or disintegration, impurities, microbial limits), in-process limits for weight, hardness, thickness and friability, stability data and conditions, validation status of the process, and certificates of analysis per batch.
03
The types below are distinguished in the guidances reviewed; each changes the size, scoring and test requirements.
| Type | What a source shows | Check |
|---|---|---|
| Immediate-release, swallowed whole | Covered by size and shape recommendations. [1] | Size, shape, coating. |
| Scored tablet | Split portions must meet whole-tablet tests. [2] | Loss of mass, friability, stability. |
| Modified-release matrix tablet | Dissolution at both hardness extremes; f2 whole vs split. [2] | Whether scoring is allowed. |
| Film-coated tablet | Coating aids mobility in swallowing. [1] | Coat type, colour, imprint. |
| Chewable, orally disintegrating | Outside the size guidance. [1] | Own criteria. |
04
The companies in the manufacturer list below show this product on their own websites. Confirm the legal seller, factory and scope for your order.
05
This is a functional reference; the composition of any tablet is set by its approved formula.
| Part | Role | Fix in the order |
|---|---|---|
| Active ingredient (API) | Delivers the dose. [3] | Strength, source, specification. |
| Filler and binder | Bulk and cohesion of the compact. | Grades and suppliers. |
| Disintegrant | Breaks the tablet up for release. | Grade, disintegration limit. |
| Lubricant | Allows compression and ejection. | Grade and level. |
| Coating | Aids swallowing, taste, protection. [1] | Film, sugar or enteric. |
| Imprint and score | Identification and dose splitting. [3] [2] | Artwork, score design. |
06
A tablet supply or development quotation needs values for your product. The table explains each field, gives published values where a reviewed source states them, and says what to obtain from the manufacturer.
| Field | What it means and published values | Ask the manufacturer for |
|---|---|---|
| Tablet weight | Weight variation is an in-process control. [4] | Target weight and limits. |
| Hardness | Splitability shown at both ends of the hardness range. [2] | Hardness range and method. |
| Thickness and diameter | Largest dimension 22 mm or less recommended. [1] | Dimensions and tolerances. |
| Disintegration time | An in-process control where appropriate. [4] | Limit and method. |
| Friability | Split portions to meet USP friability. [2] | Limit and method. |
| Dissolution | Time and rate are in-process controls. [4] | Method and acceptance. |
| Storage conditions | 25 ± 2 °C / 60 ± 5% RH for split-tablet stability. [2] | Stability protocol and shelf life. |
| Compression force, capacity, machine power and weight | Manufacturing equipment settings, not tablet properties. | Process validation data. |
07
Paste it into your enquiry below or into an email to a maker, then replace every bracket.
Product: [API; strength; release type; patient group] Physical: [size; shape; coating; colour; imprint; score] Market: [region; dossier; reference product] Quality: [release specification; in-process limits; stability] Supply: [batch size; packaging; quantity; documents]
This company lists this product on its own website.
Lists tablets among its finished dosage forms.
Product scope checked 2026-10-12
Explore company information and manufacturing capabilities, then discuss the scope of your project with a relevant supplier.
FDA recommends that the largest dimension of a tablet not exceed 22 mm. [1]
Yes, unless exempt: 21 CFR 206.10 requires a code imprint that with size, shape and colour identifies the product and its maker or distributor. [3]
Split portions should meet whole-tablet tests, lose less than 3.0% mass between segments in a 15-tablet test, and meet friability and dissolution requirements. [2]
Sources checked 2026-10-11. The FDA guidances are nonbinding recommendations; 21 CFR parts 206 and 211 are US regulations. Requirements in other markets and the specification of your product must come from its approved dossier and the manufacturer offered.
Ask for use case, specification boundaries, supplier type, and RFQ preparation information for this product.
Compare manufacturer profiles with relevant product and process capability.