Drug Data and Databases
August 3, 2026
6 minutes

Package-size code (N1, N2, N3)

The package-size code (Normgröße; N1, N2, N3) is the standardised marking of a prescription medicine's pack size in Germany, set by the Packungsgrößenverordnung under §31 SGB V. N1 is the smallest pack, N2 the medium and N3 the largest. pharmazie.com carries the code per PZN, because it is part of the substitution identity.

Table of contents
    TL;DR
    • The package-size code (Normgröße; N1, N2, N3) is the standardised marking of a prescription pack's size, set by the Packungsgrößenverordnung under §31 Abs. 4 SGB V.
    • N1 is the smallest pack (10-day target), N2 medium (30 days), N3 largest (100 days), with tolerances of ±20%, ±10% and 5% downward.
    • The code is not a fixed tablet count. Unit counts per N-code are set by substance and measure in Messzahlen that BfArM maintains.
    • A pack that fits no range carries no package-size code; a pack above the largest defined size is not reimbursable under §31 Abs. 4 SGB V.
    • Package size is an aut-idem identity criterion under §129 SGB V, so an N2 cannot substitute for an N3.
    • pharmazie.com carries the package-size code per PZN through the licensed ABDA article master data.

    The package-size code (Normgröße; N1, N2, N3) is the standardised marking of a prescription medicine's pack size in Germany, defined by the Packungsgrößenverordnung under §31 Abs. 4 SGB V. N1 marks the smallest pack, N2 the medium, N3 the largest.

    The N stands for Normgröße, meaning standard size. It answers one question: how long does this pack supply a patient, not how many tablets are inside. N1 is the small pack for acute therapy or the start of treatment, N2 the medium pack for longer therapy under medical supervision, N3 the large pack for stable chronic therapy, typically around a three-month supply. A pack that fits none of the three ranges carries no package-size code at all.

    What decides whether a pack is N1, N2 or N3?

    The classification is not a fixed tablet count. The Packungsgrößenverordnung ties each N-code to a treatment duration, expressed as a Messzahl (a target number of application units for a defined number of days), and allows a tolerance around it. Since the AMNOG reform of 2010 the durations are the same across the board, while the actual unit counts differ by substance.

    CodeTypical useTarget treatment durationPermitted deviation
    N1Acute therapy or start of treatment10 days±20%
    N2Longer therapy under medical supervision30 days±10%
    N3Stable chronic therapy100 days5% downward only

    Why is the package-size code not a fixed number of tablets?

    Because the same N-code covers different unit counts depending on the daily dose. A once-daily product reaches an N1 of ten days with roughly ten units, a three-times-daily product needs about thirty for the same ten days. Both are N1. The regulator therefore fixes, per substance and measure, the unit ranges that count as N1, N2 and N3, and BfArM maintains and publishes these Messzahlen in coordination with the Bundesministerium für Gesundheit. The logic runs like this:

    1. The regulator picks the Messgröße for the substance: piece count for solid single-dose forms such as tablets or capsules, or millilitres or grams for liquids and semi-solids.
    2. A Messzahl is set per therapy area: the number of units that covers 10 days (N1), 30 days (N2) and 100 days (N3) at the typical daily dose.
    3. A pack is assigned an N-code when its unit count falls within the relevant range including the tolerance above.
    4. A pack whose count matches no range carries no package-size code, recorded as a non-standard or "sonstige" pack.
    5. Under §31 Abs. 4 SGB V, a finished medicine larger than the largest defined pack is not part of statutory reimbursement and may not be dispensed at the expense of the statutory health insurance.

    This is why reading a fixed "N1 equals 20 tablets" rule off one product is a common error: the count is specific to the substance and its measure, not a constant.

    Why does the package-size code matter for aut-idem substitution and reimbursement?

    The package size is one of the identity criteria a pharmacy must match when it substitutes under the aut-idem rule. §129 Abs. 1 SGB V requires the substitute to be identical in strength and package size, licensed for the same indication and of the same or an interchangeable pharmaceutical form. Package size is treated as identical where the N-code matches, so an N2 pack cannot substitute for an N3, and vice versa, even when everything else lines up. The N-code therefore acts as a hard gate on which products a pharmacy may swap for one another.

    The code also interacts with pricing. Reference prices are set per pack size, so the Festbetrag and the dispensing sequence behind the Vier-günstigste-Regel are compared within the same package-size code, not across N1, N2 and N3. A manufacturer that mislabels or shifts a pack's N-code can move it into or out of a substitution and reference-price group, with direct volume consequences.

    Where does pharmazie.com carry the package-size code?

    pharmazie.com carries the package-size code (N-Kennzeichen) through the licensed ABDA article master data, alongside the price and distribution fields on the same detail page.

    • Field: the package-size code (Packungsgrößen-Kz) with the N1, N2, N3 marking, shown in the base-data section next to the generic flag, the import flag and the distribution status
    • Granularity: per PZN
    • Source: ABDA article master data (ABDATA Pharma-Daten-Service)
    • Updated: daily, with a source and date stamp on every detail page
    • Access: web app, REST API, data export

    One honest limitation: the platform records the N-code that a product carries, but it does not recompute the underlying Messzahl ranges or decide whether a given pack should have been classified differently. That determination sits with the regulator and the ordinance. The value on the page mirrors the licensed master data, and it is the right input for a substitution or reference-price check, not a substitute for the legal source.

    Sources

    Author Image
    Ursula Tschorn
    Ursula Tschorn is CEO of DACON Datenbank Consulting GmbH and has been building pharmaceutical information infrastructure since 1989. She writes on drug data standards, pricing regulation and market access in the DACH region.

    FAQ

    What do N1, N2 and N3 (Normgröße) mean on a medicine pack?
    Is the package-size code a fixed number of tablets?
    What is the legal basis of the package-size code?
    How is a pack assigned N1, N2 or N3?
    Why does the package-size code matter for aut-idem substitution?
    What happens if a pack is larger than N3?

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