TL;DRThe 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.
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.
| Code | Typical use | Target treatment duration | Permitted deviation |
|---|---|---|---|
| N1 | Acute therapy or start of treatment | 10 days | ±20% |
| N2 | Longer therapy under medical supervision | 30 days | ±10% |
| N3 | Stable chronic therapy | 100 days | 5% downward only |
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:
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.
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.
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.
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.
N1, N2 and N3 are the package-size code (Normgröße), the standardised marking on German prescription medicines set by the Packungsgrößenverordnung under §31 SGB V. N1 is the smallest pack for acute therapy, N2 the medium pack, N3 the largest for chronic therapy. The code marks how long a pack supplies a patient, not a fixed tablet count.
No. The N-code is tied to treatment duration, not a constant count. N1 targets 10 days, N2 30 days, N3 100 days, and the actual unit count depends on the daily dose. A once-daily and a three-times-daily product can both be N1 with very different tablet numbers, so counts are set per substance and measure.
The Packungsgrößenverordnung (PackungsV), issued under §31 Abs. 4 Satz 1 SGB V. That provision empowers the Bundesministerium für Gesundheit to define therapeutically appropriate and economical package sizes by ordinance. BfArM sets and publishes the Messzahl ranges that assign N1, N2 or N3 in coordination with the ministry.
The regulator sets, per substance and measure, the unit ranges that cover 10 days (N1), 30 days (N2) and 100 days (N3) at the typical daily dose, with tolerances of ±20%, ±10% and 5% downward. A pack whose count falls in a range gets that N-code. A pack fitting no range carries no Normgröße.
Package size is one of the identity criteria for substitution under §129 Abs. 1 SGB V. The substitute must match in strength and package size, which is treated as identical where the N-code matches. So a pharmacy cannot swap an N2 pack for an N3, even when the strength, indication and form all agree.
Under §31 Abs. 4 SGB V, a finished medicine whose pack exceeds the largest size defined by the Packungsgrößenverordnung is not part of statutory-health-insurance supply and may not be dispensed at the fund's expense. Such packs also carry no Normgröße, so they fall outside the standard N1 to N3 substitution logic.