Scored tablets and what the label says about them

In the federal government's public database of drug labels, as updated on Oct. 30, 2026, 774 label documents describe a tablet as having "functional scoring" or as "functionally scored." Allopurinol alone accounts for 97 of them. Warfarin accounts for none, even though 69 of the 70 prescription warfarin labels in the same openFDA drug label dataset⁶ describe their tablets as scored.

A score is the groove pressed across a tablet's face. "Functional scoring" is a labeling term FDA set out in a March 2013 guidance for industry¹ to mark tablets whose split pieces were tested against a defined set of standards. A tablet can have the groove without the tested claim.

For anyone whose prescription calls for half a tablet, the difference is worth knowing. The label wording is one of the few places a patient or caregiver can see whether a product was evaluated for splitting, and it gives a concrete starting point for a conversation with the pharmacist.

What FDA asked manufacturers to show

FDA's guidance, titled "Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation," grew out of meetings of CDER's Drug Safety Oversight Board in October 2009 and November 2010. According to the guidance¹, the board discussed how "insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the patients' dose or as a cost-saving measure." FDA then ran internal research and concluded there could be safety issues, "especially when tablets are not scored or evaluated for splitting," because split pieces can vary in drug content, weight, disintegration and dissolution.

Guidance documents are recommendations, and this one says so. It still describes what FDA reviewers look for before a new brand or generic tablet can be labeled as functionally scored.

Split pieces are also expected to pass the same finished-product tests as a whole tablet of equal strength, including the U.S. Pharmacopeia's uniformity and friability standards for immediate-release tablets. Products that fall short, FDA wrote¹, "should not have a scoring feature or any reference to scoring (including language such as bisected, etc.) in the labeling."

Where the words appear on a label

Prescription labels in the current format open with a Highlights section, and federal rules require it to say whether a product is scored. Under 21 CFR 201.57(a)(8)³, Highlights must summarize dosage forms and strengths "and whether the product is scored." Another part of the same rule requires a description of each dosage form's identifying characteristics, "including shape, color, coating, scoring, and imprinting."

FDA asks that a functionally scored product say so in three places: Dosage Forms and Strengths in the Highlights, the matching section 3 of the full prescribing information, and How Supplied in section 16. A recent allopurinol label in the openFDA dataset⁶ shows what that looks like. Its section 3 states that the 100 mg and 300 mg tablets "have functional scoring," then describes each as a "functionally scored, round tablet," with one part of its code debossed above the score line and another below it.

Labels for older products often read differently. The warfarin labels we checked describe "scored tablets" or "single-scored" tablets and never use the newer phrase. That fits the 2013 document, which says manufacturers of products already on the market "have the option" to run the assessment and update their labeling¹. When the phrase is missing, the label simply makes no claim about tested splitting. Whether a particular tablet can be split for a particular patient is a question for the prescriber and pharmacist.

To read these sections for a specific product, our guide to looking up a drug on DailyMed shows where section 3 and section 16 sit. The same description lists the code stamped on the tablet, which is how a pharmacist confirms which manufacturer's version is in the bottle.

Why a generic copies the brand's score line

FDA has treated scoring as part of whether a generic matches its brand since at least November 1995, when CDER issued an internal policy manual on the scoring configuration of generic drug products, according to the 2013 guidance¹. The guidance restates the rule in one line: "Scoring configuration of generic drug products should be the same as the RLD."

FDA gave two reasons. Consistent scoring lets a patient split a generic the same way as the brand and "switch between products made by different manufacturers without encountering problems related to the dose." It also keeps either product from gaining a market edge because one is scored and the other is not. Separately, federal regulations require a generic's proposed labeling to be the same as the labeling approved for the reference listed drug⁴, apart from a short list of permitted differences.

Color, shape and imprint are another matter, and they vary by manufacturer. Our explainer on why your pill changed color covers that, and what a generic must share with its brand sets out the rest.

What FDA's own laboratory found

Two 2010 studies by scientists in CDER's Division of Product Quality Research appear in the guidance's footnotes. The first looked at levothyroxine, a drug with a narrow therapeutic index. The researchers found the measured amount of drug did not differ significantly between whole and split tablets, but split tablets showed a higher rate of content uniformity failures⁵ than whole ones. Splitting with a tablet splitter "produced more fragmentation" than splitting by hand, the authors wrote, and imaging showed the drug was unevenly distributed inside some tablets.

The second study examined extended-release metoprolol succinate, a drug GxRadar tracks as a 50 mg tablet. Across four marketed products, it found large variation in the weight and content of split tablets and traced the problem to uneven distribution of the drug-containing beads, according to the guidance's reference list¹ and the study's published abstract⁷.

FDA's consumer page on tablet splitting², last updated in August 2013, makes the same points in plainer terms. If a tablet is approved to be split, it says, that information "will be printed in the 'HOW SUPPLIED' section" of the professional label and in the patient package insert. If not, "FDA has not evaluated it" to confirm that the halves match the whole tablet in weight, drug content or performance. The page adds that most sustained-, controlled- or timed-release medicines are not meant for splitting, and it closes with a reminder that "tablet splitting should be done only under the supervision of a healthcare professional."

How often the phrase appears, drug by drug

GxRadar searched the openFDA label dataset⁶ for prescription labels of several drugs we track and counted how many use "functional scoring" or "functionally scored" in their dosage-form or How Supplied sections. Each label document represents one product version from one labeler or repackager, so a molecule sold by many companies has many documents.

Counts cover every strength and dosage form filed under each name, and openFDA warns that its data are unvalidated. Read the shares as a rough measure of how far the 2013 vocabulary has spread across generic labels, 13 years after the guidance appeared.

For a prescription that calls for partial tablets, the label suggests a few questions to put to the pharmacist:

• Does the label for the version being dispensed describe functional scoring?
• Is this an extended-release or delayed-release product?
• Has the manufacturer changed since the last fill, and is the new version scored the same way?

FDA's recommendations also reach past approval. For manufacturing changes classed as Level 2 or Level 3 under FDA's scale-up and postapproval change guidances, it asks companies to submit a fresh evaluation of how the tablet splits, so a functional-scoring claim is meant to be rechecked when production changes.