Question 83

A new NDC number must be assigned after a substantial change in a medication's dosage form.

A new National Drug Code (NDC) number is required when there is a substantial change in a medication's dosage form, as this indicates a significant alteration in the way the drug is administered or absorbed by the body.

A) indication

While a change in indication refers to the therapeutic use of the drug, it does not require a new NDC number. Indications can change without altering the formulation or administration of the medication.

B) inactive ingredients

Changes in inactive ingredients may affect the formulation, but they do not necessarily necessitate a new NDC number unless they result in a different dosage form. Thus, this option is not correct.

C) expiration date

The expiration date is related to the stability and shelf life of the product, and changes to it do not require a new NDC number. This option does not reflect a substantial change in the medication itself.

D) dosage form

This is the correct answer because a substantial change in dosage form, such as from a tablet to a liquid, fundamentally alters how the medication is used and requires a new NDC number for regulatory purposes.

Conclusion

The requirement for a new NDC number after a substantial change in dosage form is crucial for maintaining accurate records and ensuring the proper identification of medications. Other options, while they may affect the drug, do not encompass the level of change that necessitates a new NDC number, making D the only correct choice.