Who assigns the labeler code in a current FDA-assigned NDC?
6 NDC Numbers and Product Selection Online Quiz Questions
Use this free practice quiz with 20 questions to review 6 NDC Numbers and Product Selection, test your knowledge, and prepare for your next test or exam.
True or false: In an NDC, the product code identifies the package size.
- A
True
- B
False
What is the segment-length pattern of the illustrative NDC 12345-678-90?
For a liquid medicine, 250 mg per 5 mL describes its , not the total volume in the bottle.
A prescription specifies a 250 mg/5 mL oral suspension. Which listed product matches both the specified concentration and dosage form?
- A
A 250 mg capsule
- B
A 125 mg/5 mL oral suspension
- C
A 250 mg/5 mL oral suspension
- D
A 250 mg/10 mL oral suspension
True or false: A product's inclusion in the FDA National Drug Code Directory means FDA has approved it and verified every submitted detail.
- A
True
- B
False
The FDA National Drug Code Directory is based on information by labelers.
Select all statements that accurately describe the HIPAA 11-digit NDC reporting format.
- A
It is a standardized derivative of the 10-digit FDA format.
- B
It is created by adding a zero to the beginning of every unhyphenated number.
- C
Its segments have lengths 5-4-2.
- D
It is the same format as the FDA uniform 12-digit format.
- E
The position of the added zero depends on the original hyphenated pattern.
What does the package code represent when selecting an NDC-listed product?
- A
It identifies the prescribed route.
- B
It identifies a particular package size and type, not the prescription quantity.
- C
It identifies the product's active ingredients.
- D
It identifies the labeler.
True or false: Any current 10-digit NDC can be split into its labeler, product, and package segments by counting digits from one end, even if the hyphens are missing.
- A
True
- B
False
Which actions support a reliable NDC product lookup? Select all correct choices.
- A
Choose the product with the most similar name and assume its NDC confirms a match.
- B
Compare the prescription with product labeling and an authoritative product record.
- C
Use the FDA National Drug Code Directory to check listed product information.
- D
Treat a matching ingredient as sufficient even if the dosage form or route differs.
- E
Compare the directory result with the actual product labeling and prescription.
Two products appear similar in ingredient, strength, and dosage form. Which statement about their NDCs is accurate?
- A
Products from different labelers must share an NDC if their ingredients and strength match.
- B
The brand name alone determines the full NDC.
- C
Generic and brand products, or products from different labelers, can have different NDCs even when their clinical attributes appear similar.
- D
The product code is assigned by the FDA and guarantees identical NDCs across labelers.
A system requires an 11-digit HIPAA NDC, but the available 10-digit number has no hyphens. Explain why the hyphens matter when interpreting a current 10-digit NDC and what must be established before converting it.
Who assigns the product code in an NDC?
A product is labeled “250 mg/5 mL” and comes in a 100 mL bottle. Which interpretation correctly distinguishes its concentration from the bottle’s total volume?
- A
The concentration is 100 mL, and the bottle contains 250 mg per 5 mL.
- B
The concentration is 250 mg per 5 mL, and the bottle contains 100 mL of liquid.
- C
The concentration is 250 mg in the whole bottle, and 5 mL is the bottle volume.
- D
The concentration is 5 mL, and the bottle contains 100 mg per 250 mL.
When checking a combination product against a prescription, which ingredient check is necessary?
- A
Compare only the first active ingredient; the others do not affect product matching.
- B
Match the product’s trade name, even if one active ingredient differs.
- C
Check that every active ingredient in the combination product matches the prescription.
- D
Match the package size first; that establishes the product’s active ingredients.
A product matches the prescribed ingredient and strength. What additional check is needed before selecting it?
- A
Confirm that the product is intended for the prescribed route.
- B
Assume the route is suitable whenever the ingredient and strength match.
- C
Use the package code to determine the prescribed route.
- D
Treat the route as interchangeable across dosage forms if the product name is similar.
What does the package code identify in an NDC?
- A
It identifies the prescribed quantity to dispense, regardless of the marketed container.
- B
It identifies a particular package size and type for the product.
- C
It identifies the product’s active ingredients and strength.
- D
It identifies the route for which the product is intended.
On what date is the FDA uniform 12-digit NDC format scheduled to take effect? Enter the full date in YYYY-MM-DD format.
A prescription specifies an extended-release tablet. A candidate has the same active ingredient, strength, and tablet form but is immediate-release. What product attribute prevents the candidate from matching the prescription?