6 NDC Numbers and Product Selection Free Online FlashCards

What does a National Drug Code identify?

A National Drug Code identifies a drug product and its trade package.

What does the NDC labeler code identify?

The labeler code identifies the labeler marketing the product and is assigned by FDA.

What are the three current 10-digit NDC segment patterns?

Current FDA-assigned NDCs contain 10 digits and use one of three hyphenated patterns: 4-4-2, 5-3-2, or 5-4-1.

What ingredient check is essential when selecting a product?

Check every active ingredient, especially in combination products, against the prescription.

Does an NDC package code specify the prescription quantity?

The package code identifies the marketed package size and type; it is not the prescription quantity.

What can the FDA National Drug Code Directory help verify?

Use the FDA National Drug Code Directory to check a product’s name, labeler, strength, dosage form, and listed package.

What does inclusion in the FDA NDC Directory not establish?

Directory inclusion or NDC assignment does not mean FDA approval, verify every submitted detail, guarantee current availability, or establish insurance coverage.

How is a 10-digit NDC converted to the HIPAA 11-digit format?

The HIPAA 11-digit format is a standardized derivative of the 10-digit format: add a leading zero to the appropriate segment to form 5-4-2. The zero’s position depends on the original pattern.

When is the FDA uniform 12-digit NDC format scheduled to take effect?

The FDA uniform 12-digit format is scheduled to take effect on March 7, 2033; it is distinct from the HIPAA 11-digit reporting format.

What does the NDC product code identify?

The product code identifies a particular product for that labeler, including its ingredients, strength, dosage form, and formulation.

What does the NDC package code identify?

The package code identifies a particular package size and type for the product.

Why do hyphens matter when interpreting a 10-digit NDC?

Preserve the hyphens because segment lengths vary; an unhyphenated 10-digit number cannot always be split correctly by counting from one end.