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Imprint Code FAQs - For Oral Medications

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on July 7, 2024.

What are imprint codes?

All approved prescription and over-the-counter solid, oral dosage form medications in the U.S. are required by the Food and Drug Administration (FDA) to have an imprint. This also applies to biological drug products and homeopathic drug products, unless otherwise exempted in the FDA Code of Federal Regulations 206.7. Solid oral dosage forms are defined as capsules, tablets, or similar drug products intended for oral use.

Need to identify an imprint code? Try the Drugs.com Pill Identification Wizard

You may need to identify a drug if:

Why do drugs have imprint codes?

The imprint code, when used in conjunction with the product's size, shape, and color, permits the identification of the drug product, the active ingredient(s), strength, and the manufacturer or distributor of the product.

The purpose of regulating imprinting is to enable identification of the pill ingredients and drug manufacturer by law enforcement officials, health care providers and the patient or caregiver.

There may be circumstances where two products have the same imprint code. For example, an imprint code might be reused after a drug product has been discontinued. Foreign products may also have the same code as an FDA approved imprint.

Examples of drug products that may be exempt from imprint codes (FDA Code of Federal Regulations 206.7) include investigational drugs used in research studies, placebos, drugs used in bioequivalence studies, drug products compounded by a licensed pharmacist, radiopharmaceuticals, and drugs in which printing is not physically or technically feasible, among others.

What if a pill or capsule does not have an imprint code?

A solid oral dosage form drug product that does not meet the requirement for imprinting and is not exempt from the requirement may be considered adulterated and misbranded and may be an unapproved new drug as defined by the FDA.

Also, if a pill, capsule or other dose form does not have an imprint and is not an approved medication it may be:

Do illegal drugs, or other drugs of abuse have imprints?

Some illegal drugs, such as Ecstasy, come in tablet formulations of various colors and contain an imprint or design that is appealing to a younger age group, such as a flower, a smiley face, or other common logo.

In addition, other drugs of abuse such as LSD, are often concealed in candy like Sweetarts by placing a drop of the drug on the candy. LSD is also commonly placed on sheets of paper imprinted with a design, and then smaller squares of the paper are cut out for illicit trafficking. These imprints, because they are manufactured illegally, are not available for identification in the Pill Identification Wizard.

Prescription medications that are commonly abused, such opioid painkillers, anti-anxiety benzodiazepines, or stimulants can be identified through the Pill Identification Wizard by entering the imprint codes, colors or shapes.

Patients should contact their doctor, pharmacist or other healthcare provider immediately if they cannot identify their medication.

Popular pill imprint searches

L 484 M 367 LUPIN 500 512
B 7 0 7 022 M 366 R P 5 325
10/325 M523 PLIVA 433 30 M M 365
R 0 3 9 R 180 4H2 R P 10
X ANA X 2 S 90 3 RP 10 325 TEVA 3927
K 56 H 49 377 1 2


Learn More:
Identifying manufacturer imprints and logos

Definitions

See also

Sources

  1. U.S. Food and Drug Administration. CFR - Code of Federal Regulations Title 21, Vol. 4 (21CFR206) Subchapter C. Part 206 - Imprinting of Solid Oral Dosage Form Drug Products for Human Use. Revised March 22,2024. Accessed July 7, 2024 at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=206&showFR=1 
  2. US Food and Drug Administration (FDA). Homeopathic Products. Updated Feb. 11, 2020. Accessed July 7, 2024 at https://www.fda.gov/drugs/information-drug-class/homeopathic-products

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.