- In the National Drug Code (NDC) number 0078-0458-05, which segment identifies the manufacturer or labeler?
Answer: 78
The NDC number is divided into three segments. The first segment, in this case '0078', is the labeler code, which identifies the manufacturer or distributor of the drug. The second segment identifies the product, and the third identifies the package size.
- What is the primary function of the National Drug Code (NDC) in a pharmacy?
Answer: To uniquely identify a specific drug, manufacturer, and package size
The NDC is a universal product identifier for human drugs in the United States. Its primary purpose is to provide a unique identifier for a specific labeler (manufacturer), product (drug/strength/form), and package size, which is essential for accurate dispensing, billing, and inventory control.
- A technician needs to bill an NDC that appears as 12345-1234-1 on the stock bottle. What is the correct 11-digit format for this NDC?
Answer: 12345-1234-01
The standard 11-digit NDC format is 5-4-2. The provided 10-digit NDC is in a 5-4-1 format. To convert it, a leading zero must be added to the segment that is short of the standard format. In this case, the third segment ('1') is short, so it becomes '01', resulting in the correct 11-digit NDC of '12345-1234-01'.
- For insurance submission, a technician must convert the 10-digit NDC 12345-678-90 into the 11-digit format. What is the correct conversion?
Answer: 12345-0678-90
To convert a 10-digit NDC to the 11-digit HIPAA standard (5-4-2 format), a leading zero must be added to the deficient segment. For a 5-3-2 format like '12345-678-90', the middle (product code) segment is short. Therefore, a zero is added to the beginning of that segment, resulting in '12345-0678-90'.
- The labeler code, which is the first segment of every NDC number, is uniquely assigned to each manufacturer by which organization?
Answer: The Food and Drug Administration (FDA)
The FDA is the government agency responsible for regulating drugs in the United States. As part of this role, the FDA assigns a unique labeler code to each company that manufactures or distributes drugs.
- What is the most likely reason for this discrepancy and the technician's most appropriate action?
Answer: The package sizes are different; the technician should verify the prescribed quantity and notify the pharmacist.
The first two segments of the NDC ('0781-2613') match, indicating the manufacturer and drug product are correct. The third segment, the package code, is different ('01' vs. '05'). This signifies a different package size (e.g., 100-count bottle vs. 500-count bottle). The technician must investigate and inform the pharmacist.
- What information is provided by the final segment of an NDC number?
Answer: The package configuration and size
The third and final segment of the NDC is the package code. This part of the code is assigned by the manufacturer to identify different package configurations and sizes of the same product, such as a 30-count bottle, a 90-count bottle, or a box of 10 unit-dose vials.
- While entering a prescription, a technician scans a drug's barcode, but the system states "NDC not found." Which of the following is a possible reason for this message?
Answer: The drug is a newly released product not yet added to the database.
An "NDC not found" error means the specific product identifier is not present in the pharmacy's drug file. This commonly occurs when a drug is new to the market, is from a new generic manufacturer, or has been repackaged and the pharmacy's database has not yet been updated. The other options relate to different stages of prescription processing (billing or clinical review).
- A pharmacy technician prepares a non-sterile compound of "Magic Mouthwash" according to a physician's prescription. When entering the compound into the computer system for labeling and billing, what NDC should be used?
Answer: A pharmacy-specific or universal placeholder NDC designated for compounds.
Extemporaneously compounded medications are not manufactured products and therefore do not have an FDA-assigned NDC. Pharmacy computer systems use a specific, non-official placeholder NDC to process the prescription, create a label, and bill for the compound as a whole. Using the NDC of an ingredient or a different commercial product would constitute billing fraud.
- A prescription requires billing using an 11-digit NDC. The manufacturer's label shows the 10-digit NDC as 1234-5678-90. How should this be converted to the HIPAA-standard 11-digit format (5-4-2)?
Answer: 01234-5678-90
The HIPAA standard for NDC billing is an 11-digit number in a 5-4-2 format. To convert a 10-digit NDC, a leading zero is added to the segment that is short. In a 4-4-2 format like '1234-5678-90', the first segment is short, so a zero is added to the beginning, resulting in '01234-5678-90'.
- In a pharmacy utilizing barcode scanning and an automated inventory system, the NDC number is primarily used to:
Answer: Track inventory levels and automate the reordering process
The barcode on a drug package contains the NDC number. When a technician scans the product during dispensing or receiving, the pharmacy's computer system automatically updates the inventory count. This allows for accurate tracking of stock levels and can trigger automatic reorders when a product falls below its par level.
- A pharmacy technician is verifying a stock bottle with the NDC 68180-512-01. Which part of this NDC identifies the specific drug, strength, and dosage form?
Answer: 512
The middle segment of the NDC is the product code. In this example, '512' identifies the specifics of the drug itself, including its active ingredient, strength, and dosage form. The first segment ('68180') is the labeler code, and the third segment ('01') is the package code.
- A drug manufacturer's label contains several numbers. Which of the following is used to verify that the correct medication and package size have been selected for dispensing?
Answer: NDC number
While the lot number and expiration date are critical for safety and quality assurance (e.g., in case of a recall), the NDC number is the specific identifier used to verify that the product being dispensed matches the product ordered on the prescription, including the correct manufacturer, drug, strength, dosage form, and package size.
- What is the BEST method for the technician to verify the correct drug was selected?
Answer: Compare the NDC on the stock bottle to the NDC in the dispensing system.
Hydroxyzine and hydralazine are classic look-alike/sound-alike (LASA) drugs. While confirming spelling is a good first step, it is prone to error. The most reliable method to ensure the correct drug is selected is to use barcode scanning or manual comparison of the NDC number on the stock bottle with the NDC number specified in the prescription processing software.
- The NDC on the unit-dose blister pack of the same medication will most likely:
Answer: differ in the third segment, which indicates package size.
The first segment (manufacturer) and second segment (product and strength) will be the same because it is the same drug from the same company. However, the third segment (package code) must be different to distinguish the 100-count bulk bottle from the unit-dose blister pack. Note: If a third-party company repackaged the drug, the first segment would also change, but the package code will always be different for different package types.
- When a drug manufacturer issues a Class I recall, how is the NDC number utilized by the pharmacy?
Answer: To identify and quarantine the specific products affected by the recall
A drug recall notice specifies the exact products affected by listing their NDC numbers and lot numbers. Pharmacy staff use this information to search their physical inventory and computer records to locate, isolate, and return the recalled medication, preventing it from being dispensed to patients.
- The NDC for a bottle of 100 tablets is 59762-3701-1. What does the '1' in the third segment of this NDC typically represent?
Answer: The package size or type
The third and final segment of an NDC number is the package code. This segment identifies the package size (e.g., 100-count bottle, 30-count blister pack) and type. The DEA schedule, lot number, and therapeutic class are not part of the NDC.
- When a pharmacy technician compares the NDC on a prescription to a stock bottle, the middle segment of the code provides what critical information?
Answer: The specific strength, dosage form, and formulation of the drug
The middle segment of the NDC is the product code. It is assigned by the manufacturer to identify the specific product, which includes its active ingredient(s), strength, and dosage form (e.g., tablet, capsule, injection). The first segment identifies the manufacturer, and the third segment identifies the package size.
- Why is it critical for a pharmacy technician to ensure the correct 11-digit NDC is submitted on an insurance claim?
Answer: To ensure proper reimbursement and prevent claim rejections
Insurance payers use the 11-digit NDC to identify the exact product that was dispensed. Submitting an incorrect NDC can lead to the claim being rejected or the pharmacy being reimbursed incorrectly. Accurate NDC submission is crucial for the financial viability of the pharmacy.
- The first segment of a National Drug Code (NDC) is assigned by the FDA and identifies the:
Answer: Labeler
The Food and Drug Administration (FDA) assigns the first segment of the NDC, known as the labeler code. This code uniquely identifies the company that manufactures, repacks, or distributes the drug product.
